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Study identifier: NCT07559864 Synced from ClinicalTrials.gov · July 28, 2026
● 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

Condition: GIST - Gastrointestinal Stromal Tumor · KIT Gene Mutation  ·  Sponsor: Jian Li

PhasePhase 2
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jian Li, MD  ·  +86 010 88196561  ·  oncogene@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Beijing Cancer HospitalBeijing, Beijing Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07559864