Actively Recruiting
Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment
Led by Jian Li · Updated on 2026-04-30
100
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastrointestinal stromal tumors (GISTs) are mostly driven by c-kit or PDGFRA mutations, and commonly occur in the stomach and small intestine. Targeted therapy is the mainstay for advanced metastatic GISTs, but there is a lack of effective regimens after drug resistance. Immune checkpoint inhibitors (ICIs) have limited efficacy as monotherapy, while tyrosine kinase inhibitor (TKI) drugs such as regorafenib can improve the immune microenvironment and exert a synergistic effect when combined with ICIs, with more significant efficacy especially in cases with kit exon 17 mutations. This study aims to explore the effectiveness of regorafenib combined with envafolimab in metastatic gastrointestinal stromal tumors with kit exon 17 mutations that have failed standard treatment.
CONDITIONS
Official Title
Comparing Regorafenib Combined With Envafolimab to Physician's Choice in Patients With Metastatic Gastrointestinal Stromal Tumors Harboring KIT Exon 17 Mutations Refractory to Standard Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 918 years or older, any gender
- Confirmed diagnosis of gastrointestinal stromal tumor by histopathology
- At least one measurable target lesion per mRECIST v1.1 criteria with recent imaging within 14 days before first treatment
- Disease progression or intolerance after prior treatment with imatinib, sunitinib, regorafenib, or ripretinib
- Presence of primary or secondary KIT exon 17 mutation confirmed by genetic testing
- Adequate organ and bone marrow function as specified (ANC 91.5x10^9/L; platelets 975x10^9/L; hemoglobin 99.0 g/dL; liver, kidney, and coagulation parameters within defined limits)
- Ability to provide 15 paraffin-embedded tissue sections for immune testing
- ECOG performance status score of 0 to 2
- Signed informed consent form
You will not qualify if you...
- History of intolerance to regorafenib or prior immune checkpoint inhibitor therapy
- Pregnant or breastfeeding women
- Expected survival less than 3 months
- Major surgery or significant trauma within 4 weeks before screening or planned during the study
- Current active ulcers or gastrointestinal bleeding
- History of interstitial lung disease, non-infectious pneumonia, or active tuberculosis
- Uncontrolled pleural effusion, pericardial effusion, or ascites needing repeated drainage
- Clinically confirmed autoimmune diseases, HIV, HCV, high HBV-DNA, or acute CMV infection
- Central nervous system metastases
- Other malignancies within the past 5 years
- Immunosuppression or current systemic steroid use (except recent inhaled steroids)
- Uncontrolled hypertension despite treatment (systolic 960 mmHg or diastolic 900 mmHg on three measurements)
- Inability or unwillingness to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100101
Actively Recruiting
Research Team
J
Jian Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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