Delving into the Latest Updates on Capecitabine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Capecitabine (JAN/USP/INN), Capecitabine RDT, pentyl 1-(5-deoxy-β-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate

+ [18]

Target

TYMS

Action

inhibitors

Mechanism

TYMS inhibitors(Thymidylate synthase inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [6]

Active Indication

Gastrooesophageal junction cancerPancreatic CancerRectal Cancer+ [26]

Inactive Indication

Adenocarcinomaadenocarcinoma of biliary tractAdenocarcinoma of Esophagus+ [93]

Originator Organization

F. Hoffmann-La Roche Ltd.

Active Organization

medac Gesellschaft für klinische Spezialpräparate mbH

Bayer AGAccord Healthcare SLU

+ [12]

Inactive Organization

Sanofi

Bristol Myers Squibb Co.

Genentech, Inc.

+ [17]

License Organization

Qingdao Baheal Medical, Inc.

CHEPLAPHARM Arzneimittel GmbH

Roche Holding AG

Drug Highest PhaseApproved

First Approval Date

United States (30 Apr 1998),

Metastatic breast cancer

RegulationAccelerated Approval (United States)

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Structure/Sequence

Molecular FormulaC15H22FN3O6

InChIKeyGAGWJHPBXLXJQN-UORFTKCHSA-N

CAS Registry154361-50-9

This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.

Start Date31 Dec 2025

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

NCT05375708

/ SuspendedPhase 2IIT

A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer

A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.

Start Date01 Dec 2025

Sponsor / Collaborator

University Medical Center of Utrecht

NCT06291064

/ Not yet recruitingPhase 2IIT

TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).
All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Start Date01 Nov 2025

Sponsor / Collaborator

The University of Chicago

100 Clinical Results associated with Capecitabine

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100 Translational Medicine associated with Capecitabine

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100 Patents (Medical) associated with Capecitabine

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13,528

Literatures (Medical) associated with Capecitabine

01 Dec 2025·Journal of Gastrointestinal Cancer

Impact of Retroperitoneal Lymphadenopathy (RPLN) on the Outcomes of Locally Advanced Gall Bladder Cancer (GBC) Following Chemotherapy (CT) or Chemotherapy Followed by Consolidation Chemoradiotherapy (CTRT)

Article

Author: Naik, Nagendra ; Priyanka, Parul ; Agrawal, Sushma

INTRODUCTION:

Retroperitoneal lymphadenopathy is considered a metastatic disease in GBC; however, some surgical series of radical surgery with enlarged RPLN who underwent RPLN dissection have shown results marginally inferior to those without enlarged RPLN. Radiological RPLN comprises a major proportion of advanced non-metastatic GBC. There is dilemma in the intent of treatment to be offered in such cases. We are reporting our series of outcome of GBC with RPLN treated with first-line CT followed by consolidation CTRT.

MATERIALS AND METHODS:

Non-metastatic locally advanced GBC with good performance status (KPS ≥ 80) were initiated on first-line CT (cisplatin-gemcitabine), and thereafter, responders were evaluated by CECT-angiography and PET-CT scan for resectability. If found unresectable, they were offered consolidation CTRT to a dose of 45 Gy by conventional fractionation (3D-CRT technique) along with concurrent capecitabine at 1250 mg/m² to GBC and regional lymphatics including RPLN. Thereafter, boost dose of 9 Gy/5# was given to GBC only. Response assessment was done using CECT abdomen by RECIST criteria v 1.1. Outcomes (overall survival) of the two groups (RPLN vs non-RPLN) were computed with Kaplan-Meier survival curves and chi-square tests using SPSS v 20.

RESULTS:

Among 189 patients of advanced non-metastatic GBC recruited from 2011 to 2022, 80 had RPLN. The demographic features of both groups were comparable. Overall, 68% of the patients were women, 30% underwent upfront stenting for obstructive jaundice, and 90% had T3 and T4 disease. Only 10% had undergone upfront laparoscopic staging and had pathologically proven RPLN. Forty percent of the patients received four cycles of CT only and 50% of the patients received six cycles or more and 33% received CTRT. By RECIST criteria, 10% vs 16% achieved complete response (CR), 39% vs 41% achieved partial response (PR), 16% vs 15% achieved stable disease (SD), 2.7% vs 6% had disease progression (PD), and 14.5% vs 3.7% were non-evaluable in non-RPLN group vs RPLN group, respectively. 12% vs 6% could undergo radical surgery in non-RPLN group vs RPLN group (p = 0.03). The median OS was 9 months (95% CI 7.6-10.3 months) vs 10 months (95% CI 8-9.8 months) (p = NS) in non-RPLN group vs RPLN group, respectively. In those who received CT only, the median OS was 7 months vs 8 months, while in those who received CT followed by CTRT, the median OS was 14 months vs 13 months (p = 0.65) in non-RPLN group vs RPLN group, respectively.

CONCLUSIONS:

Based on this analysis, we conclude that RPLN constitutes a major proportion of advanced non-metastatic GBC and has outcomes similar to those without RPLN if treated with radical intent. RPLN should not be considered a metastatic disease and should be treated with radical intent.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Dihydropyrimidine enzyme activity and its effect on chemotherapy toxicity: importance of genetic testing

Article

Author: Villano, John L ; Roberts, Danielle ; Pandey, Deepali ; Williams, Abby ; Shamaei Zadeh, Alexia

PURPOSE:

Patients with partial or complete DPD deficiency have decreased capacity to degrade fluorouracil and are at risk of developing toxicity, which can be even life-threatening.

CASE:

A 43-year-old man with moderately differentiated rectal adenocarcinoma on capecitabine presented to the emergency department with complaints of nausea, vomiting, diarrhea, weakness, and lower abdominal pain for several days. Laboratory findings include grade 4 neutropenia (ANC 10) and thrombocytopenia (platelets 36,000). Capecitabine is used as a component of first-line adjuvant therapy by approximately 2 million patients worldwide each year. Capecitabine is metabolized to fluorouracil via the enzyme dihydropyrimidine dehydrogenase (DPD). With worsening pancytopenia and diarrhea, genetic testing for DPD deficiency was sent. Prompt treatment with uridine triacetate was initiated for presumed DPD deficiency. Unfortunately, he passed away from an infectious complication and was later confirmed to have a heterozygous DPYD*2A mutation.

DISCUSSION:

Our case demonstrates uneven testing guidelines for DPD prior to initiating 5-FU chemotherapy, appropriateness of treating with uridine triacetate, and analysis of next-generation sequencing (NGS) on tumor samples and co-incidentally obtaining germline DPD deficiency status. Our case also highlights the severe clinical impact of having DPD deficiency even with early uridine triacetate therapy.

CONCLUSION:

It is our recommendation to perform DPD deficiency in curative intent cancer treatment and this information can increasingly be obtained in standard tumor NGS profiling, a growing norm in medical oncology.

01 Dec 2025·Journal of Gastrointestinal Cancer

Development of a Prognostic Nomogram for Overall Survival in Gastric Cancer Patients Who Underwent Adjuvant Chemoradiotherapy

Article

Author: Avci, Hanife ; Ozyurek, Yasin ; Hurmuz, Pervin ; Dag, Osman ; Yigit, Ecem ; Yilmaz, Melek Tugce ; Cengiz, Mustafa

PURPOSE:

The aim of this study was to identify prognostic factors influencing overall survival (OS) in patients with gastric cancer treated with adjuvant chemoradiotherapy (CRT) and to develop a predictive model.

METHODS:

We retrospectively evaluated 245 non-metastatic gastric cancer patients who received adjuvant CRT or radiotherapy from 2010 to 2020. Survival analyses were performed using the Kaplan-Meier method. Prognostic factors were identified through univariate and multivariate Cox regression analyses. A nomogram was constructed based on significant predictive factors for OS, including lymph node ratio, T classification, tumor location, and local recurrence.

RESULTS:

The median follow-up duration was 41.5 months (range, 6-144.8 months). The 2- and 5-year OS and progression-free survival were 77% and 53% and 64% and 49%, respectively. In multivariate analysis, tumor location (distal vs. proximal), pT classification (pT1-2 vs. pT3-4), lymph node ratio (< 0.18 vs. ≥ 0.18), and presence of local recurrence were independent prognostic factors for OS. The optimal cut-off value for the total nomogram score predicting OS was 116 points. Patients with < 116 points had 2- and 5-year OS rates of 87% and 73%, respectively, compared to 67% and 30% for those with ≥ 116 points.

CONCLUSION:

A nomogram was constructed incorporating lymph node ratio, T classification, tumor site, and local recurrence for gastric cancer patients receiving adjuvant CRT. Patients with a total score below 116 demonstrated higher survival rates. This nomogram may aid in defining optimal follow-up intervals.

406

News (Medical) associated with Capecitabine

01 Jul 2025

·www.fiercebiotech.com

Processa hands cancer candidate back to Opus Genetics after deciding milestone out of reach

“After determining that the time and cost required to advance PCS3117 to a meaningful milestone would be too high, Processa has terminated the license agreement,” the company said.\n After several years of development, Processa Pharmaceuticals has determined that the nearest milestone for anticancer asset PCS3117 is still too far away. Instead, the biotech is handing the oral analog of Eli Lilly’s Gemzar back to Opus Genetics.“After determining that the time and cost required to advance PCS3117 to a meaningful milestone would be too high, Processa has terminated the license agreement,” the company said in a July 1 business update.The portfolio streamlining is meant to help Processa focus on another oncology asset, a modification of a precursor molecule of approved chemotherapy 5-fluorouracil, sold as Adrucil by Teva Pharmaceuticals. Processa is currently enrolling patients in a phase 2 metastatic breast cancer trial for this candidate, called next-generation capecitabine, according to the release. “We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact,” David Young, Ph.D., Processa’s president of research and development, said in the release. “Our approach continues to center on developing safer, more effective treatments for cancer while creating value through strategic business development and disciplined pipeline management.” Processa first licensed PCS3117 from Opus—then known as Ocuphire Pharma—in June 2021. Under the terms of that deal, Processa gained the exclusive worldwide right to develop and commercialize PCS3117 outside China. After securing the asset, Processa ran a 46-patient phase 1/2 trial in metastatic pancreatic cancer that wrapped up in 2023.PCS3117, known as next-generation gemcitabine, is turned into its active form by a different enzyme system than Gemzar once in the body, according to Processa. This means the candidate could be used in patients who have resistance to Gemzar. Processa said in August 2024 that it intended to convene with the FDA to discuss the design for PCS3117’s next trial later that year or in early 2025.For its part, Occuphire only acquired the asset through a 2020 merger with Rexahn Pharmaceuticals. In 2024, Ocuphire transformed itself into a gene therapy outfit through the acquisition of Opus Genetics, adopting the latter’s name and launching a focus on inherited retinal diseases.Aside from next-gen capecitabine, Processa also has an analog of irinotecan, which is commonly used in combination with capecitabine and fluorouracil, in development.

License out/inAcquisitionPhase 2Gene Therapy

01 Jul 2025

·www.globenewswire.com

Processa Pharmaceuticals Provides Portfolio and Business Update

Signed binding term sheet granting Intact Therapeutics an exclusive option to license PCS12852Continue enrolling patients in Phase 2 study of PCS6422Strengthened balance sheet with $7M capital infusion VERO BEACH, Fla., July 01, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company developing next-generation cancer therapies, provides updates on its product pipeline, upcoming milestones and business activities. “We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact,” said Dr. David Young, President Research and Development at Processa. “Our approach continues to center on developing safer, more effective treatments for cancer while creating value through strategic business development and disciplined pipeline management.” “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is actively enrolling patients. We continue to anticipate sharing initial data in the second half of 2025,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “The streamlining of our development pipeline, signing of strategic partnerships, and optimizing our capital allocation, enable us to make the necessary investments in our science in order to enhance shareholder value.” Key Portfolio Updates: PCS6422 (NGC-Cap): PCS6422, Processa’s lead oncology asset in combination with capecitabine (NGC-Cap), is actively enrolling patients in a Phase 2 study for metastatic breast cancer. The program remains a top priority, with the remaining patients needed for the pre-planned interim analysis expected to be enrolled in the second half of 2025. The trial builds on compelling safety and efficacy signals observed in earlier studies, including improved tolerability and increased exposure to active cancer-killing metabolites.PCS499: Based on preliminary positive results in kidney disease and the FDA allowing surrogate endpoints to now be used in rare kidney diseases, Processa is currently designing a new adaptive pivotal PCS499 Phase III study to discuss with the FDA later this year. In addition, Processa is establishing a dedicated subsidiary to hold PCS499. The move is intended to enhance strategic flexibility in targeting capital raising and potential partnership exploration after meeting with the FDA. PCS12852: As previously announced, Processa has signed a binding term sheet with Intact Therapeutics, Inc. granting an exclusive option to license PCS12852 for gastroparesis and related gastrointestinal motility disorders. Under the terms, Processa is eligible for up to $454 million in milestone payments, a 12% royalty on future sales, and a 3.5% equity stake in Intact. The partnership represents a strategic monetization of non-core assets while maintaining upside potential.PCS11T: PCS11T is Processa’s preclinical oncology asset based on the active metabolite of irinotecan. The company continues to define and explore preclinical and clinical development strategies as well as opportunities to support future development.PCS3117: After determining that the time and cost required to advance PCS3117 to a meaningful milestone would be too high, Processa has terminated the license agreement for PCS3117 and returning the rights to the original licensor. Commitment to Shareholder Value These portfolio changes align with Processa’s strategic intent to focus on oncology assets with strong differentiation, scientific rationale, commercial opportunity and clear regulatory pathways. The company believes this will optimize our human and capital resources, expedite the unlocking of hidden asset value through partnerships, and position the organization to deliver long-term shareholder returns. Investor Webinar Processa CEO George Ng will participate in a live investor webinar on Wednesday, July 9, 2025, at 4:15 p.m. ET to discuss the company’s strategic pipeline realignment and value-creating milestones. To register for the free webinar, please visit: https://www.redchip.com/webinar/PCSA/85765532754 Questions can be pre-submitted to PCSA@redchip.com or online during the live event. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations:Dave GentryRedChip Companies, Inc.1-407-644-4256PCSA@redchip.com

License out/inPhase 2Phase 3

30 May 2025

·www.globenewswire.com

Processa Pharmaceuticals Announces Presentation and Publication of Three Abstracts at 2025 ASCO Annual Meeting

HANOVER, Md., May 30, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation cancer therapies with improved efficacy and safety, today announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. The abstracts highlight Processa’s pipeline of Next Generation Cancer (NGC) drug candidates, including PCS6422 (NGC-Cap) and PCS11T (NGC-Iri), showcasing both preclinical and clinical advances. Trials in Progress Poster Presentation and Abstract Publication Abstract Title: Adaptive Designed Eniluracil + Capecitabine Phase 2 Trial in Advanced or Metastatic Breast Cancer PatientsAbstract Number: TPS1133 | Poster Board Number: 105bSession Title: Breast Cancer—MetastaticDate & Time: June 2, 2025 | 9:00 AM–12:00 PM CDTDr. David Young, Founder and President of Research & Development at Processa, will be presenting an overview of Processa’s ongoing Phase 2 adaptive design trial evaluating the safety and efficacy of PCS6422 (eniluracil) combined with capecitabine in patients with advanced or metastatic breast cancer. The study explores optimal dosing regimens and a personalized medicine approach to improve outcomes and tolerability. Abstract Publications 1. Abstract Title: Safety and Efficacy of Eniluracil + Capecitabine (6422 + Cap) in Phase 1b Trial Abstract Number: e15152 This online-only abstract provides data from the Phase 1b study that defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap (eniluracil + capecitabine or 6422 + Cap), highlighting its improved safety profile and anti-tumor activity compared to standard capecitabine. 2. Abstract Title: Preclinical Project Optimus Dose Escalation of SN-38 Pro-Drug PCS11T Abstract Number: e15023 This online-only abstract outlines a Project Optimus-aligned approach to define the optimal therapeutic window of PCS11T, a tumor-targeted pro-drug of SN-38. PCS11T is designed to increase drug concentration in tumors while reducing systemic toxicity. “These ASCO presentations and publications reflect the breadth of our oncology pipeline and the progress we’re making across multiple programs,” said Dr. David Young. “From our Phase 2 clinical program in metastatic breast cancer to preclinical innovations with PCS11T, we are leveraging our Regulatory Science Approach and deep oncology expertise to address critical unmet needs.” About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations:Dave GentryRedChip Companies, Inc.1-407-644-4256PCSA@redchip.com

ASCOPhase 1Phase 2

100 Deals associated with Capecitabine

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External Link

KEGG	Wiki	ATC	Drug Bank
D01223	Capecitabine	L01BC06	DB01101

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastrooesophageal junction cancer	United States	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Pancreatic Cancer	United States	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Rectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	19 Sep 2016
Esophageal Carcinoma	Australia	Dr. Reddy's Laboratories (Australia) Pty Ltd.	24 Jun 2013
Locally advanced breast cancer	European Union	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	European Union	KRKA dd	20 Apr 2012
Locally advanced breast cancer	European Union	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	Iceland	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	Iceland	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	Iceland	KRKA dd	20 Apr 2012
Locally advanced breast cancer	Liechtenstein	KRKA dd	20 Apr 2012
Locally advanced breast cancer	Liechtenstein	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	Liechtenstein	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	Norway	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	Norway	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	Norway	KRKA dd	20 Apr 2012
Stomach Cancer	China	Chugai Pharmaceutical Co., Ltd.	17 Oct 2008
Breast cancer recurrent	Japan	CHEPLAPHARM Arzneimittel GmbH	12 Dec 2007
Colonic Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	30 Apr 2003
Advanced gastric carcinoma	European Union	CHEPLAPHARM Arzneimittel GmbH	02 Feb 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	France	UNICANCER	11 Jun 2020
GRPR Positive/ER Positive/HER2 Negative Breast Cancer	Phase 3	France	UNICANCER	11 Jun 2020
Liver metastases	Phase 3	France	UNICANCER	11 Jun 2020
Metastatic gastric adenocarcinoma	Phase 3	United States	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Japan	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Argentina	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Belgium	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Canada	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Czechia	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Denmark	Eli Lilly & Co.	20 Jan 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03904043 (NOM-ERA, CTgov)	Not Applicable	Rectal Adenocarcinoma	63	Radiation therapy (Radiation + FOLFOX)	skqjbgciro = qqcufkahih mkbuqqcrsg (eurrgqlizy, ugiflejmji - ttwhvkrpbb) View more	-	11 Jun 2025
				Radiation therapy+oxaliplatin+capecitabine (Radiation + CAPOX)	skqjbgciro = vmfuhawbxz mkbuqqcrsg (eurrgqlizy, juotiianxf - rcecfpbmfl) View more
NCT01354522 (Pubmed \| Cancer Commun (Lond))	Phase 3	HER2-negative breast cancer Adjuvant	204	Docetaxel, Anthracycline, Cyclophosphamide (TAC)	vijzbufevw(qirbpjcgax) = kxtwtfcyng ggbaejbhoi (yxcqyemvdq, 3.9) View more	Positive	09 Jun 2025
				Docetaxel, Cyclophosphamide, Capecitabine (TCX)	vijzbufevw(qirbpjcgax) = huuemqtnbr ggbaejbhoi (yxcqyemvdq, 4.7) View more
NCT04849364 (PERSEVERE, CTgov)	Phase 2	Triple Negative Breast Cancer	52	pembrolizumab+inavolisib+capecitabine (Arm 1c: ctDNA Positive Genomically Directed - PI3K Pathway)	mkrgdfsxom = rpqipxohzs njtyiuqyjn (uhscmugriu, uulalqodtt - mgmfbasnmy) View more	-	31 May 2025
				Pembrolizumab+Capecitabine (Arm 2: ctDNA Positive - Standard of Care)	aupfmzsevg = wanwoygxuy ckixnqjtur (aviidjaozc, aayhtorzmw - wgolwgtpns) View more
NCT02595320 (ASCO2025)	Phase 2	Metastatic breast cancer	182	Fixed-dose Capecitabine 1500 mg	hrnkxejvpm(qahwzbhalj) = azwdbgyiar hxhuxufccd (feabnaclbz ) View more	Positive	30 May 2025
				Standard-dose Capecitabine 1250 mg	hrnkxejvpm(qahwzbhalj) = onjwbrndoq hxhuxufccd (feabnaclbz ) View more
ASCO2025	Not Applicable	Head and Neck Neoplasms	86	Capecitabine 500mg twice a day + Erlotinib 150mg daily	nsajmwwwdw(wjfnpigrqh) = ivyjktgxqh oblaoqvavo (qojsvbqyiz, 1.22 - 1.90) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Esophageal Squamous Cell Carcinoma	50	Capecitabine plus Oxaliplatin (CapOx)	qgfosovbtg(ohadkcpqlg) = mostly grade 1 & 2 and not significantly different in 2 arms dluftwddrt (ayuknlicpg ) View more	Negative	30 May 2025
				Paclitaxel plus Carboplatin (PC)
NCT05064085 (Phase I trial of capecitabine with cemiplimab, ASCO2025)	Phase 1	Hormone receptor positive breast cancer	-	Capecitabine + Cemiplimab	myazqilogc(emwtqhgouj) = orihgooinu mkhqclfrkc (jztkjwlkbn, 35.5% - 82.3%) View more	Positive	30 May 2025
ATS2025	Not Applicable	Metastatic breast cancer Adjuvant	-	Capecitabine	kazlssnxls(abludzvkyr) = She started cycle #1 of capecitabine and 2 weeks later presented to the hospital with cough and dyspnea, requiring admission for sepsis secondary to viral pneumonia with lung infiltrates seen on imaging. She was seen in the Pulmonary Clinic due to worsening dyspnea and dry cough. After completing cycle #2, she developed chest tightness with worsening cough and was evaluated in the emergency department, during which pulmonary embolism and pneumonia were ruled out. She was given steroids again with good relief. Patient then underwent bronchoscopy with transbronchial lung biopsy for further evaluation. Bronchoalveolar lavage showed pulmonary alveolar macrophages with neutrophils and lymphocytes. Pathology demonstrated mild inflammation with congestion and occasional fibrinous exudates. Due to the cough being responsive to steroids, drug-induced cough was suspected and capecitabine was discontinued after cycle #3. Steroids were repeated with significant improvement in her cough. ecuxbontey (jozsifnbsp ) View more	-	16 May 2025
NCT02767661 (MECCA Trial, Pubmed \| J Clin Oncol)	Phase 3	Hormone receptor positive HER2 negative breast cancer hormone receptor-positive+ \| HER2-negative	263	Metronomic Capecitabine plus Aromatase Inhibitor	jovvqtilgn(omvovceiny) = cfyimplazo gjakoxwzid (vbitgmiraj ) View more	Positive	10 Apr 2025
				Aromatase Inhibitor alone	jovvqtilgn(omvovceiny) = gtpexhimli gjakoxwzid (vbitgmiraj ) View more
P1-6.012 (AAN2025)	Not Applicable	Seizures \| Leukoencephalopathies	-	Capecitabine	ktxjdrhdjj(seacdxpmdb) = Neurological adverse effects are uncommon, typically presenting with acute confusion, ataxia, and dysarthria xsluzdjuol (whrcwabieq ) View more	-	07 Apr 2025