ChiCTR2600126996 Sintilimab Metastatic Gastrointestinal Stromal Tumor Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines ChiCTR2600126996—A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Regorafenib in Combination with Sintilimab and Radiotherapy versus Regorafenib Monotherapy in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) Who Have Failed at Least Two Prior Tyrosine Kinase Inhibitors Including Imatinib (TIR-GIST)—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why ChiCTR2600126996 is a hot trial to watch

Metastatic Gastrointestinal Stromal Tumor is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. ChiCTR2600126996 is notable because it evaluates Sintilimab in a Phase 3 design while Contrast-enhanced CT or MRI assessed according to RECIST v1.1; the primary endpoint is determined by blinded independent central review (BICR). serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The phase label is only the starting point. Allocation is Not reported, masking is Open Label, and the intervention model is Parallel Assignment. Planned enrollment of 45 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Secondary: Survival status and date of death are confirmed through clinic / hospital records, telephone follow-up, family contact, or local medical records; estimated using the Kaplan-Meier method. (From randomization to death from any cause.)
• Secondary: Determined by BICR according to RECIST v1.1; DCR is defined as the proportion of participants with CR, PR, or stable disease (SD lasting >=12 weeks) (Assessed at each scheduled post-randomization tumor assessment; stable disease must persist for at least 12 weeks.)
• Secondary: AEs/SAEs are graded and recorded according to NCI CTCAE v5.0, including severity, causality, action taken, and outcome. Events of special interest include immune-related AEs, radiotherapy-related toxicities, Grade ≥3 AEs, SAEs, and AEs leading to treatment interruption or discontinuation. (AEs are recorded from the time of informed consent.)
• Secondary: Best overall response is determined by BICR according to RECIST v1.1; ORR is defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) (Assessed at each scheduled post-randomization tumor assessment)
• Primary: Contrast-enhanced CT or MRI assessed according to RECIST v1.1; the primary endpoint is determined by blinded independent central review (BICR). (From randomization to the first documented radiographic disease progression or death from any cause)

Benchmark readouts in the surrounding field

• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide, or Tirzepatide for the Treatment of Obesity (Phase 2): Incremental Postprandial Triglycerides (TG)(Mean) = 43.81 percent change (Standard Deviation, 92.373); Incremental Postprandial Triglycerides (TG)(Mean) = -51.91 percent change (Standard Deviation, 72.293)
• A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women (Phase 2): Interval From First Dose to Evidence of Ovulation.(Mean) = 2.67 Number of days (Standard Deviation, 1.53); Interval From First Dose to Evidence of Ovulation.(Mean) = 4.0 Number of days (Standard Deviation, 0)
• A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight (Phase 2): Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -0.4 percent change (Standard Error, 0.91); Percent Change From Baseline in Body Weight at Week 48(Least Squares Mean) = -9.4 percent change (Standard Error, 1.60)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

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Asset and sponsor context

Drug & Asset context: Sintilimab (Approved; PD-1); Regorafenib (Approved; BRAF V600E x CRAF x CSF-1R x DDR2 x EphA2 x FGFR1 x FRK x MAPK11 x PDGFRα x PDGFRβ x RET x Tie-2 x TrkA x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit)

Company & Deal Intelligence context: Sun Yat-Sen University Cancer Center — China — http://english.sysucc.org.cn

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Sequencing evidence: comparative data after the most relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

ChiCTR2600126996 is a focused lens on Metastatic Gastrointestinal Stromal Tumor development. Its value will be determined by whether Sintilimab can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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