Status:
RECRUITING
Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Detailed Description
ripretinib is the standard fourth-line treatment agent for inoperable advanced GIST patients, but the mPFS is only 6.3 months. Prolonging the time to TKI resistance by using a new treatment approach i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06507683
Start Date
May 28 2024
End Date
July 1 2027
Last Update
July 18 2024
Active Locations (1)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016