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Compares treatment options for GIST - Gastrointestinal Stromal Tumor
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
ClinicalTrials.gov ID: NCT07559864
What this study is testing
What is physician-selected treatment?
physician-selected treatment is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for gist - gastrointestinal stromal tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥ 18 years, regardless of gender;
- Confirmed as gastrointestinal stromal tumor by histopathological examination;
- Having at least one measurable target lesion meeting the criteria of mRECIST v1.1 (non-lymph node lesions with a long axis ≥ 1.0 cm or a long axis ≥...
- Disease progression or intolerance after treatment with imatinib, sunitinib, regorafenib, or ripretinib;
- Primary or secondary KIT exon 17 mutation detected by genetic testing;
You likely can't join if
- A history of intolerance to regorafenib treatment, or previous receipt of immune checkpoint inhibitor therapy;
- Being in pregnancy or lactation;
- Those with an expected survival period of less than 3 months;
- Those who have undergone major surgery or suffered significant trauma within 4 weeks before the first blood collection during the screening period...
- Patients with current active ulcers or gastrointestinal bleeding;
- A history of interstitial lung disease or non-infectious pneumonia; a history of active tuberculosis;
See the full eligibility criteria
- Aged ≥ 18 years, regardless of gender;
- Confirmed as gastrointestinal stromal tumor by histopathological examination;
- Having at least one measurable target lesion meeting the criteria of mRECIST v1.1 (non-lymph node lesions with a long axis ≥ 1.0 cm or a long axis ≥ the thickness of 2 slides); imaging assessment should be performed...
- Disease progression or intolerance after treatment with imatinib, sunitinib, regorafenib, or ripretinib;
- Primary or secondary KIT exon 17 mutation detected by genetic testing;
- Sufficient organ and bone marrow function, defined as follows: Blood routine: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 75×10⁹/L; hemoglobin (HGB) ≥ 9.0 g/dL. No use of granulocyte...
- Provide 15 paraffin-embedded tissue sections before enrollment for immune microenvironment detection;
- ECOG PS score of 0-2;
- Signed informed consent form.
- A history of intolerance to regorafenib treatment, or previous receipt of immune checkpoint inhibitor therapy;
- Being in pregnancy or lactation;
- Those with an expected survival period of less than 3 months;
- Those who have undergone major surgery or suffered significant trauma within 4 weeks before the first blood collection during the screening period, or are expected to require major surgery during the study period;
- Patients with current active ulcers or gastrointestinal bleeding;
- A history of interstitial lung disease or non-infectious pneumonia; a history of active tuberculosis;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Patients with clinically confirmed autoimmune diseases; those with positive HIV or HCV; those with HBV-DNA exceeding the laboratory normal range; those with acute CMV infection;
- Patients with clinically confirmed central nervous system metastases;
- Patients with other malignant tumors within 5 years;
- Immunosuppressed people, including those with known immunodeficiency; those currently receiving systemic steroid medications (except those who have used inhaled steroids recently or currently);
- Uncontrolled hypertension: After active antihypertensive treatment, three consecutive blood pressure measurements indicate systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg;
- people who, in the investigator's assessment, are unable or unwilling to comply with the requirements of the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.