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A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment

NCT06772233 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-31

No results posted yet for this study

Summary

This study is a multicenter, prospective, randomized controlled Phase II clinical trial. The primary endpoint is to evaluate the efficacy and safety of regorafenib combined with envafolimab compared to physician's choice in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

Conditions

  • Metastatic Gastrointestinal Stromal Tumors (GIST)

Interventions

DRUG

regorafenib combined with envafolimab

-Regorafenib: Specification: 40 mg/tablet Dosage: 120 mg, taken orally once daily for 3 weeks, followed by 1 week off, until disease progression or intolerable toxicity occurs. * Envafolimab: Specification: 200 mg/vial Dosage: 200 mg, administered via subcutaneous injection once every 2 weeks, until disease progression or intolerable toxicity occurs.

DRUG

Control Group

The governing principle for physician decision-making in the control group was selection based on prior medication tolerability, genotype, etc.: a. Continued maintenance therapy with the originally effective TKI at the same dose: The patient achieved at least stable disease (SD) or partial response (PR) during prior treatment, with progression-free survival (PFS) exceeding 6 months, and the adverse reactions were tolerable. b. Combination therapy with two TKIs: Different drugs were selected for maintenance based on distinct actionable mutations identified in the patient's tissue or peripheral blood genetic testing, OR a combination of drugs previously effective and well-tolerated was used, OR the combination therapy was chosen by referencing past tolerability.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Jian Li, Dr. · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2027-07-30
Completion
2028-07-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06772233 on ClinicalTrials.gov