Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
A Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
First Affiliated Hospital of Chongqing Medical University
32 participants
May 28, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST. It will also learn about the safety of this regimen.The main questions it aim to answer is: Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST?
Eligibility
Inclusion Criteria7
- Voluntary participation and signed informed consent;
- age: 18 to 75 years, Male or female
- Patients with histologically confirmed GIST and Imaging evaluated as unresectable recurrent and metastatic disease or locally advanced.
- ECOG Performance Score: 0-2
- Subjects who have progressed or documented intolerance after previous first-line, second-line, and third-line treatments.
- At least one measurable lesion in the abdominal or pelvic cavity that has progressed after frontline treatment
- Adequate organ function and bone marrow reserve
Exclusion Criteria4
- estimated life-expectancy less than 3 months.
- Patients who have received previous radiotherapy to the proposed radiotherapy site, or the tumor has significant mobility, poor tolerance of radiotherapy in adjacent organs, and who are considered unsuitable for radiotherapy after MDT discussion
- Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
- If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period
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Interventions
A cumulative radiation dose of 50 to 70 Gy is administered in 25-30 fractions, 5 fractions per week, to the target lesion(s). ripretinib: oral 150mg QD
Locations(1)
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NCT06507683