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

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

Gastrointestinal Stromal Tumor

Recruiting

2

Start Date 01/01/2025

Age of Trial (yrs) .1

Gleevec-resistant

PD-L1 Antibody + KIT/PDGFRA inhibitor

Specifically GIST and only GIST

GIST 006

Peking University

Jian Li, Dr. :+861088196088 oncogene@163.com

Randomized

Oral Intravenous

Study Overview

Brief 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 previously effective maintenance regimens in patients with metastatic gastrointestinal stromal tumors harboring KIT exon 17 mutations who have failed standard treatments.

Detailed Description

This multicenter, prospective, randomized controlled phase II clinical trial aims to explore the efficacy and safety of Regorafenib combined with envafolimab in treating metastatic GIST with KIT exon 17 mutation that has failed standard treatment. It also seeks to investigate the correlation between the immune microenvironment and the efficacy of immunotherapy. The study includes patients with histologically confirmed advanced metastatic GIST containing the KIT exon 17 mutation, requiring at least one evaluable lesion. Using a block randomization method, the study is open-label and assigns patients to either the treatment group or the control group in a 1:1 ratio. The treatment group receives Regorafenib combined with envafolimab, while the control group continues with previously effective targeted drugs until disease progression, intolerable toxicity, or voluntary withdrawal from the trial. A total of 82 patients are planned to be enrolled, with imaging assessments conducted at baseline and every two months during treatment.

Partial eligibility requirements ( See NCT listing for full requirements)

Inclusion Criteria:

Age ≥ 18 years, no gender restriction;
Pathologically confirmed gastrointestinal stromal tumor (GIST);
At least one measurable target lesion according to mRECIST v1.1 criteria (non-lymph node lesion with a long axis ≥ 1.0 cm or long axis ≥ 2 slide thicknesses); imaging assessment within 14 days before the first dose;
Progression or intolerance after treatment with imatinib, sunitinib, regorafenib, or ripretinib;
Genetic testing includes primary or secondary KIT exon 17 mutation;

Exclusion Criteria:

Unable to tolerate previous regorafenib treatment or previously received immune checkpoint inhibitors;
Pregnant or breastfeeding;
Expected survival less than 3 months;