Status:
UNKNOWN
Ripretinib Combined With Surgery in Advanced GIST That Have Failed Imatinib Therapy: A Multicenter,Observational Study
Lead Sponsor:
Sichuan Provincial People's Hospital
Conditions:
Gastrointestinal Stromal Tumor(GIST)
Eligibility:
All Genders
18-75 years
Brief Summary
The objective of this observational study is to explore the efficacy and safety of ripretinib treatment combined with surgery in advanced gastrointestinal stromal tumors(GIST) after failure of imatini...
Detailed Description
This study is a single-arm, multicenter, observational study. A total of approximately 30 subjects were be enrolled. The patient was orally administered with ripretinib150 mg QD. 4 weeks for one cycle...
Eligibility Criteria
Inclusion
- Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
- 18 years ≤ age \< 75 years, male or female;
- Histopathological examination confirmed the diagnosis of recurrent and/or metastatic advanced unresectable gastrointestinal stromal tumor;
- According to the modified RECISTv1.1-GIST-specific criteria, the subject has at least one measurable lesion;
- Subjects must have progressed on imatinib or have documented intolerance to imatinib.
- ECOG PS of ≤ 2, ASA score ≤ 3 at screening;
- No other malignant tumors occurred within five years;
Exclusion
- Molecular pathology report PDGFRA Exon 18 mutation(including D842v);
- Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc;
- Pregnant or lactating women;
- Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line treatment should not be enrolled.
- Subject has known active central nervous system metastases.
- Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
- The patient has participated in or is participating in other clinical studies , or is taking other TKI agents;
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05354388
Start Date
October 1 2021
End Date
December 30 2023
Last Update
April 29 2022
Active Locations (1)
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1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072