Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer

To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.

Start Date30 Nov 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07146646

/ Not yet recruitingPhase 2IIT

A Phase II Trial of Trifluridine/Tipiracil Plus Oxaliplatin in Patients With Advanced or Metastatic Biliary Tract Cancer Following First-Line Therapy

Participants are eligible for this study who were treated for advanced biliary tract cancer (BTC) but the treatment either did not make the cancer better or is no longer working. The treatment for patients whose advanced BTC either did not make the cancer better or is no longer working is a combination of chemotherapy drugs called FOLFOX which consists of fluorouracil and oxaliplatin. Studies have shown that other treatments may work better to treat advanced BTC. In this study, investigators want to see if treating patients with the drug combination of trifluridine/tipiracil (FTD/TPI) and another drug called oxaliplatin works better than FOLFOX for advanced BTC as second-line therapy. FTD/TPI are pills that are taken by mouth, whereas oxaliplatin is given intravenously (by IV).

Start Date01 Oct 2025

Sponsor / Collaborator

The Case Comprehensive Cancer Center

[+1]

NCT07196345

/ Not yet recruitingPhase 1/2IIT

Efficacy and Safety of Trifluridine/Tipiracil Combined With Radiotherapy in Elderly Patients With Locally Advanced Esophageal Cancer

This study is a single-arm, multicenter clinical trial evaluating the efficacy and safety of radiotherapy combined with TAS-102 monotherapy in elderly patients with locally advanced esophageal cancer.
Treatment Phase: The treatment phase is divided into a Phase I stage and a Phase II stage. The Phase I stage aims to explore the maximum tolerated dose (MTD) of TAS-102 in elderly esophageal cancer patients. A total of 9 subjects were enrolled, and the dose was escalated from 30 mg/m² in 5 mg/m² increments up to 40 mg/m². The MTD was defined as the highest drug dose at which no dose-limiting toxicity (DLT) was observed in more than 40% of treated patients during the first two weeks of combined radiotherapy and TAS-102 administration. The Phase II stage aims to investigate the efficacy of radiotherapy combined with TAS-102 at the MTD in elderly esophageal cancer patients, with 36 subjects enrolled.
Consolidation Phase: Following the treatment phase, subjects had a 3-4 week rest period. This was followed by consolidation therapy with TAS-102 monotherapy at a dose of 35 mg/m², administered twice daily on days 1-5 of a 28-day cycle for two cycles.
Subsequently, patients entered the efficacy and safety follow-up phase until the study endpoints were reached or after a full 2-year follow-up period.

Start Date25 Sep 2025

Sponsor / Collaborator

Qianfoshan Hospital of Shandong Province

100 Clinical Results associated with Tipiracil Hydrochloride/Trifluridine

100 Translational Medicine associated with Tipiracil Hydrochloride/Trifluridine

100 Patents (Medical) associated with Tipiracil Hydrochloride/Trifluridine

437

Literatures (Medical) associated with Tipiracil Hydrochloride/Trifluridine

01 Nov 2025·Translational Oncology

A CEBPB/TYMP/GDF15 signaling axis mediates tumor growth and cisplatin resistance in bladder cancer

Article

Author: Zhang, Xu ; Zhao, Xupeng ; Xuan, Yundong ; Zhang, Chi ; Huang, Yan ; Tian, Shuo ; Tao, Wen ; Dong, Yuhao ; Wei, Wenjie ; Wang, Chuang ; Cai, Tianwei ; Liu, Chunyu

Cisplatin-based chemotherapy remains the standard treatment for muscle-invasive bladder cancer (BC), yet resistance significantly limits its long-term efficacy. Reliable biomarkers for prognosis and therapeutic guidance are also lacking. Here, we identify thymidine phosphorylase (TYMP) as an independent prognostic risk factor that promotes BC progression and mediates cisplatin resistance. Bioinformatic analyses of TCGA and GEO datasets revealed elevated TYMP expression in BC tissues, correlating with poor patient outcomes. Functional studies in UMUC3, T24, and MB49 cell lines, as well as in syngeneic mouse models, demonstrated that TYMP knockdown suppressed BC cell proliferation, migration, invasion, and epithelial-mesenchymal transition (EMT), while enhancing cisplatin sensitivity. Pharmacological inhibition of TYMP using TAS-102 significantly augmented cisplatin-induced cytotoxicity in vivo. Mechanistically, the transcription factor CEBPB directly bound to and activated the TYMP promoter, thereby upregulating GDF15 expression and driving tumor growth and chemoresistance. TYMP expression positively correlated with both CEBPB and GDF15 levels in public datasets. Collectively, our findings define a CEBPB/TYMP/GDF15 signaling axis that fosters BC progression and cisplatin resistance and highlight TYMP as a novel prognostic biomarker and potential therapeutic target, with TAS-102 offering a promising strategy for overcoming cisplatin resistance.

01 Oct 2025·Photodiagnosis and Photodynamic Therapy

A novel approach in colon cancer treatment: successful conversion of locally advanced colon cancer using endoscopic rendezvous technique combined with multimodal therapy—A case report and literature review

Review

Author: Wang, Yunpeng ; Xu, Bo ; Jiang, Jingyi ; Hu, Jike ; Sun, Guodong ; Chen, Hao ; Pu, Weigao

This case report explores the potential of endoscopic photodynamic therapy (PDT) to downstage locally advanced colon cancer (LACC) and enhance patient quality of life. A young female with obstructive LACC, unresponsive to CapeOX chemotherapy, underwent emergency colostomy followed by dual-route endoscopic PDT. Subsequent neoadjuvant therapy, including TAS-102, targeted agents, and immunotherapy, led to a partial tumor response. This enabled fluorescence-guided radical resection and stoma reversal. The patient achieved favorable postoperative recovery, with symptomatic relief, decreased tumor marker levels, and no evidence of disease (NED). This case demonstrates that endoscopic PDT combined with multimodal systemic therapy can facilitate successful conversion surgery and bowel function restoration in treatment-refractory LACC.

01 Sep 2025·EUROPEAN JOURNAL OF CANCER

Impact of trifluridine/tipiracil plus bevacizumab on tumor shrinkage and depth of response in refractory metastatic colorectal cancer: analysis of the SUNLIGHT trial

Article

Author: Fakih, Marwan ; Taieb, Julien ; Ciardiello, Fortunato ; Amellal, Nadia ; Roby, Lucas ; Prager, Gerald W ; Barboux, Valentine ; Elez, Elena ; Van Cutsem, Eric ; Modest, Dominik P ; Bragagnoli, Arinilda Campos ; Gravalos, Cristina

OBJECTIVES:

This post hoc analysis of the SUNLIGHT trial sought to assess the response to treatment with trifluridine/tipiracil (FTD/TPI) + bevacizumab and FTD/TPI in patients with refractory metastatic colorectal cancer using tumor shrinkage (TS), early TS (ETS), duration of TS (DTS) and depth of response (DpR) as response-related parameters.

METHODS:

TS was defined as any decrease from baseline of the sum of the longest diameter of target lesions. TS at first assessment was specified as ETS. DpR was defined as the maximum percentage change from baseline of the sum of the longest diameters of target lesions. DTS was defined as the time from first TS to first increase in tumor size, progressive disease, or death.

RESULTS:

In the FTD/TPI + bevacizumab group, 48 % had TS and 39 % had ETS. In the FTD/TPI group, 21 % had TS and 17 % had ETS. In patients achieving ETS, median DTS was prolonged with FTD/TPI + bevacizumab compared to FTD/TPI (3.8 versus 2.1 months; HR: 0.34 [95 % CI: 0.22, 0.53]; P < 0.0001). Magnitude of DpR was greater with FTD/TPI + bevacizumab than with FTD/TPI.

CONCLUSION:

The survival benefit of treatment with FTD/TPI + bevacizumab versus FTD/TPI is likely associated with the improvement of ETS and DpR.

127

News (Medical) associated with Tipiracil Hydrochloride/Trifluridine

28 Oct 2025

·oncolyticsbiotech.com

Oncolytics Biotech® Reports Updated Anal Cancer Data Showing Objective Response Rate More Than Double the Current Standard of Care

Pelareorep plus atezolizumab achieves 30% ORR in second-line or later (≥2L) squamous cell anal carcinoma (SCAC) relative to 13.8% for the FDA-approved 2L treatment The median duration of response was 15.5 months compared to 9.5 months for the current standard of care Company expects to discuss single-arm accelerated approval study with FDA in Q1 2026 SAN DIEGO, Calif., Oct. 28, 2025 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced updated results from the single-arm squamous cell anal carcinoma (SCAC) cohort of the GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with ≥2L metastatic SCAC. Patients from this cohort continue to be followed, and additional efficacy data are expected to be reported. The combination of pelareorep and atezolizumab achieved an objective response rate (ORR) of 30% (six among 20 evaluable patients). This represents a greater than 2x improvement over the historical benchmark of 13.8% ORR reported for the only FDA-approved immunotherapy for 2L SCAC. Importantly, there have been two durable complete responses among the six responders, with one ongoing beyond two years, and the other lasting 15 months. In addition, another patient has an ongoing response at 64 weeks. The overall median duration of response for patients receiving pelareorep and atezolizumab is 15.5 months compared to 9.5 months for the current standard of care at this stage of treatment. These updated results from this ongoing SCAC cohort reinforce the potential of pelareorep to drive durable immunologic tumor control in gastrointestinal tumors. The results also demonstrate the durability and depth of responses achievable with the combination of pelareorep and checkpoint inhibitors without chemotherapy. “This is the most encouraging efficacy signal with a non-chemo regimen we have ever seen in anal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. “Achieving a 30% objective response rate — more than double the benchmark of the only approved immunotherapy — along with multiple responses lasting more than a year, including two complete responses, underscores pelareorep’s ability to unlock deep and durable immune responses. We believe the data represent our best chance to obtain an accelerated approval in a rare disease with virtually no options outside of chemotherapy.” The SCAC cohort is part of Oncolytics’ broader GOBLET study, a Phase 1/2 trial evaluating pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications, including pancreatic, colorectal, and anal cancers. Based on these compelling data, Oncolytics intends to engage the U.S. Food and Drug Administration (FDA) to discuss a potential single-arm study designed for accelerated approval in second-line or later SCAC, with a potential launch date for such a study expected in the first half of 2026. About GOBLET The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; expectations regarding the outcome of an upcoming regulatory meeting, including in relation to the Company’s proposed design of potential pancreatic and anal cancer registration studies; expectations relating to outcomes of ongoing and future studies; Oncolytic s’ plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic pancreatic and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon PattonDirector of IR & Communicationjpatton@oncolytics.caInvestor Relations for OncolyticsMike MoyerLifeSci Advisors+1-617-308-4306mmoyer@lifesciadvisors.comMedia Contact for OncolyticsOwen BlaschakLifeSci Communicationsoblaschak@lifescicomms.com Logo: https://mma.prnewswire.com/media/2408622/5586029/Oncolytics_Biotech_Inc_Logo.jpg SOURCE Oncolytics Biotech® Inc.

Clinical ResultImmunotherapyFast TrackPhase 2Accelerated Approval

21 Oct 2025

·www.biospace.com

Exelixis’ Kinase Blocker Sets ‘New Survival Bar’ in Third-Line Colorectal Cancer, Opening Road to FDA

iStock, Yutthana Gaetgeaw With data from the Phase III STELLAR-303 study in the books, Exelixis is plotting a 2025 regulatory application for zanzalintinib. Exelixis is plotting its path to the FDA after its oral kinase inhibitor zanzalintinib significantly improved overall survival in a Phase III study of patients with a specific type of metastatic colorectal cancer. The data come from the Phase III STELLAR-303 study, which showed that at a median follow-up of 18 months, zanzalintinib plus Roche’s Tecentriq resulted in a median overall survival (OS) of 10.9 months. Comparators treated with Bayer’s Stivarga, meanwhile, hit median OS of 9.4 months. 12- and 24-month OS estimates were 46% and 20% in the zanzalintinib group versus 38% and 10% in the Stivarga arm. Exelixis presented the STELLAR-303 readout Monday at the 2025 meeting of the European Society for Medical Oncology (ESMO) and simultaneously published these findings in The Lancet . The company expects to submit a regulatory application for zanzalintinib by year-end. In a note to investors on Monday, William Blair said zanzalintinib “sets a new survival bar in the third-line or later mCRC [metastatic colorectal cancer] setting.” Being mindful of “limitations and caveats” of cross-study comparisons, the analysts pointed out that the current record in this setting is held by Taiho Oncology’s Lonsurf chemotherapy and Roche’s Avastin, which yielded an OS of 10.8 months. “The STELLAR-303 trial marks the first pivotal success from the zanzalintinib program,” William Blair wrote, noting that it currently models mCRC sales of $24 million in the U.S. next year, reaching a peak figure of $850 million. William Blair had previously modeled $4.5 billion in U.S. sales for zanzalintinib across all its indications by 2033, and Monday’s data “represent the first step toward achieving this goal,” the analysts added. STELLAR-303 is a Phase III open-label trial that enrolled more than 900 patients with mCRC who had undergone prior lines of treatment. Aside from OS, Monday’s readout also demonstrated a trend toward progression-free survival improvement, though the study’s design precluded statistical analysis “at this time,” according to Exelixis. As for safety, the biotech reported that 59% of patients in the zanzalintinib arm developed grade 3/4 treatment-related toxicities, as opposed to 37% of controls; 18% of those given the kinase inhibitor had to drop out of the study because of side effects. Of note, there were two deaths that were deemed related to zanzalintinib, while one other mortality was attributed to the combo regimen. “We view the 60% grade 3 and 4 treatment-related adverse event frequency as potentially burdensome for patients,” William Blair wrote on Monday, though the analysts did not directly address the deaths. Nevertheless, the firm questioned “the risk/benefit calculus” of adding Tecentriq to zanzalintinib, noting its “potential to increase side effects and out-of-pocket costs for patients.”

Phase 3Clinical ResultASCO

21 Oct 2025

·www.pharmaceutical-technology.com

ESMO 2025: MSD’s ADC leapfrogs to Phase III in colorectal cancer

Merck KGaA will progress its ADC, precemtabart tocentecan, to Phase III trials following the positive readout of the Phase I PROCEADE-CRC-01 study in heavily pretreated colorectal cancer. Image credit: Jo Panuwat D via ShutterStock.com. MSD’s antibody-drug conjugate (ADC), precemtabart tocentecan (Precem-TcT), has shown promising efficacy during an early-stage trial in heavily pretreated colorectal cancer. Thus far in the ongoing Phase I PROCEADE-CRC-01 study (NCT05464030), the drug has triggered an objective response rate (ORR) of 31% in patients at a dose of 2.8 mg/kg. Precem-TcT also had a positive impact on progression-free survival (PFS), with the median value reaching 6.9 months in the treatment group. In addition, 64.3% of patients given the therapy remained free of disease progression at the six-month mark. Meanwhile, the drug was found to be safe and tolerable, with the most common Grade 3 treatment-emergent adverse events (TEAEs) being neutropenia and anaemia. While gastrointestinal (GI) TEAEs were observed, they were always mild-to-moderate, with no Grade 3 GI events recorded during the trial. These results were first presented in a late-breaking oral presentation at the ongoing 2025 European Society of Medical Oncology (ESMO) congress, which is being held in Berlin, Germany between 17–21 October. The outcome of the PROCEADE-CRC-01 study will be welcome news for MSD –known as Merck in the US – as the drug bested its potential rival, telisotuzumab adizutecan. In its respective Phase I study, the c-Met-targeting ADC triggered an ORR of 26.7%, according to a topline readout presented by AbbVie at ESMO. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Future directions for Precem-TcT In conversation with Pharmaceutical Technology , Victoria Zazulina, senior VP, head of development unit oncology at MSD, noted that the competition to commercialise a widely applicable ADC in colorectal cancer is stiff. “The industry is on the brink of a breakthrough, though it is yet to be seen who makes it to market first,” she said. In the world of ADCs, Zazulina believes that the “devil is in the detail”, as the type of chemotherapy you combine with a specific payload can play a key role in a drug’s efficacy and subsequent success. “What we are learning as an industry is that the chemotherapy we want to direct to a disease such as colorectal cancer needs to be one that we know that indication will respond to,” Zazulina said. “This has led to the explosion of ADCs using the Topoisomerase 1 (Top1) payload, which Precem-TcT employs.” Precem-TcT functions by selectively targeting and killing cancer cells that express the surface protein carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) – a target that has garnered prior intrigue but, thus far, disappointing results. While Sanofi canned the development programme for its anti-CEACAM5 ADC tusamitamab in 2023, Zazulina noted that MSD has a “renewed interest” in the target, as a new payload class could demonstrate better efficacy in solid tumour indications. To further explore this hypothesis, MSD will take Precem-TcT straight to Phase III trials in colorectal cancer, which Zazulina expects to initiate in the first half of 2026. Combination could be key to early-line CRC treatment Despite Precem-TcT’s promising clinical activity in colorectal cancer thus far, Zazulina believes that combination approaches “should not be disregarded”. “Precem-TcT may be suitable as a monotherapy in later treatment settings, but in the first or second lines, it will most likely require a combination,” Zazulina stated. This is primarily due to the higher prevalence of options in these settings, making it harder to best current standard of care (SoC) combination regimens like TAS-102 (trifluridine/tipiracil) plus bevacizumab. “MSD’s overall vision for ADCs like Precem-TcT is more to replace certain chemotherapy components, rather than to completely remove or outperform the whole regimen. However, we will use TAS-102 plus bevacizumab as our control arm Phase III, and see how the data pan out,” added Zazulina. Precem-TcT’s role in gastrointestinal cancers While Zazulina noted that colorectal cancer was a perfect place to start in the Precem-TcT development journey due the company’s legacy and the disease’s strong expression of CEACAM5, MSD is eyeing the drug’s potential in further indications. “There is this gastrointestinal theme around CEACAM5 expression, with indications like pancreatic and gastric cancer all showing reasonably high expression of CEACAM5,” Zazulina commented. However, as the expression of this target will not be the near 100% seen in colorectal cancer, MSD will likely need to identify patients who may benefit from treatment with Precem-TcT, as “not everybody will exhibit the same level of target expression or ADC trafficking towards the tumour,” Zazulina caveats. To explore its potential in gastrointestinal cancers and beyond, MSD is running trials in pancreatic, gastric and non-small cell lung cancer (NSCLC). “All of our studies in these indications are currently recruiting patients, and we will soon be sharing results at some upcoming medical conferences,” Zazulina concluded. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. 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Phase 1Phase 3Clinical ResultADCASCO

100 Deals associated with Tipiracil Hydrochloride/Trifluridine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tipiracil Hydrochloride/Trifluridine	L01BC	DB08937

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2-positive gastric cancer	South Korea	Jeil Pharmaceutical Co., Ltd.	17 Oct 2019
Metastatic Gastric Carcinoma	Australia	Servier Laboratories (Australia) Pty Ltd.	23 May 2017
Metastatic Gastroesophageal Junction Adenocarcinoma	Australia	Servier Laboratories (Australia) Pty Ltd.	23 May 2017
Gastroesophageal junction adenocarcinoma	European Union	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Iceland	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Liechtenstein	Les Laboratoires Servier SAS	25 Apr 2016
Gastroesophageal junction adenocarcinoma	Norway	Les Laboratoires Servier SAS	25 Apr 2016
Metastatic Colorectal Carcinoma	United States	Taiho Oncology, Inc.	22 Sep 2015
Colorectal Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014
Stomach Cancer	Japan	Taiho Pharmaceutical Co., Ltd.	24 Mar 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	United States	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Japan	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Belgium	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Denmark	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Finland	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Hungary	Institut Servier de Medecine Translationnelle SARL	21 Apr 2022
Adenocarcinoma of large intestine	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025
Dihydropyrimidine Dehydrogenase Deficiency	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025
Gastrooesophageal junction cancer	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025
Rectal Cancer	Phase 2	France	Les Laboratoires Servier SAS	21 Mar 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06245356 (TRIFLUOX-DP, ESMO2025)	Phase 2	Metastatic gastroesophageal adenocarcinoma \| Metastatic Colorectal Carcinoma First line dihydropyrimidine dehydrogenase deficiency (DPD)	74	Trifluridine/Tipiracil (T/T) + oxaliplatin +/- targeted therapies	mmryufdtmd(dgusigqfhx) = tpgatmgkof jngvjejblg (gqcxugeora ) View more	Positive	17 Oct 2025
ReTrITA (ESMO2025)	Not Applicable	Metastatic Colorectal Carcinoma	344	anti-EGFR (T/R sequence)	yatknlpdug(yikpffugwb) = itolpjlste olabhujiwq (idcfwkznzi ) View more	Positive	17 Oct 2025
				anti-EGFR (R/T sequence)	yatknlpdug(yikpffugwb) = pfuvgswxjb olabhujiwq (idcfwkznzi ) View more
NCT04564898 (TRICOMB, ESMO2025)	Phase 2	Metastatic Colorectal Carcinoma First line	38	Trifluridine/tipiracil + capecitabine + bevacizumab	erkelxyktn(uavvygmtnd) = oligbyskqr mmejtzaldp (tdbsjvesph, 38 - 67) View more	Positive	17 Oct 2025
NCT05481463 (Pubmed \| Mol Cancer)	Phase 2	Metastatic Pancreatic Cancer Third line \| Last line	22	TAS-102 plus Surufatinib	irbdghevch(cojkadkizk) = rimhkdaoqt gxhhnsdehw (qexebfmgci, 3.81 - 10.09) View more	Positive	02 Oct 2025
ESMO_GI2025	Not Applicable	Metastatic Colorectal Carcinoma NRAS mutations	87	TAS-102 (Good Prognosis Group)	jnnfsvwtng(qqbioojqyq) = fraqitrqqx clrnrlbeaa (oytyaqnbrd ) View more	Positive	03 Jul 2025
				TAS-102 (Poor Prognosis Group)	jnnfsvwtng(qqbioojqyq) = strvybrhlq clrnrlbeaa (oytyaqnbrd ) View more
Trifluridine/tipiracil plus bevacizumab vs regorafenib (ESMO_GI2025)	Not Applicable	Refractory Colorectal Carcinoma oxaliplatin \| irinotecan \| fluoropyrimidine-based chemotherapy ... View more	1,483	Trifluridine/tipiracil plus bevacizumab (TTB)	vujwxjvvtl(qshrjfudmj) = alxbokbgkv rvohcnlhlg (mbkqnkeeao )	Positive	03 Jul 2025
				Regorafenib (R)	vujwxjvvtl(qshrjfudmj) = vvbgbnaeww rvohcnlhlg (mbkqnkeeao )
NCT04059562 (TRITICC, ESMO_GI2025)	Phase 2	Bile Duct Neoplasms Second line	28	Trifluridine/Tipiracil + Irinotecan	bilpkrdivz(czoihswmzo) = zddyvitofz xgngckhlhg (gkoczpwmgd ) View more	Positive	03 Jul 2025
JPRN-UMIN000041621 (Pooled safety analysis of trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) for metastatic colorectal cancer (mCRC), ESMO_GI2025)	Not Applicable	Metastatic Colorectal Carcinoma Last line	292	trifluridine/tipiracil (FTD/TPI) (FTD/TPI plus BEV)	tqdzystnnc(ctitixuunm) = 51% vs. 82% gwmfvmujmx (ykxzlwylgd ) View more	-	03 Jul 2025
				trifluridine/tipiracil (FTD/TPI) (FTD/TPI)
ChiCTR2300075853 (BETTER Study, ESMO_GI2025)	Phase 2	Metastatic Colorectal Carcinoma Third line MSS \| pMMR	30	Tislelizumab 200mg	krlxnrouni(dulgbbiitu) = xjdwoqkkxr tmnaohxdoz (hqnlwemuor ) View more	Positive	03 Jul 2025
NCT05343013 (INTERCEPT-TT, Pubmed \| JCO Precis Oncol)	Phase 2	Colorectal Cancer ctDNA	15	TAS-102 35 mg/m2	jvfkovfskn(wtxhltwqhp) = itrhhhwxtd vyljiecxlw (iaasppqmwe )	Negative	01 Jul 2025
				Standard of care	jvfkovfskn(wtxhltwqhp) = ftsjfkjgyx vyljiecxlw (iaasppqmwe )

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis