Ripretinib Combined With Surgery in Advanced GIST That Have Failed Imatinib Therapy: A Multicenter,Observational Study

Study Overview
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Brief Summary
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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 imatinib therapy.

Detailed Description
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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. Efficacy was assessed every two cycles. For subjects with PR or SD after ripretinib treatment, resection of gastrointestinal stromal tumor was performed after discussion by MDT and ensure R0 resection as much as possible.Ripretinib 150mg QD was continued 2 weeks after surgery. Thereafter, subjectss entered the follow-up period for at least 1 year. Safety and survival information will be collected

Official Title
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Ripretinib Combined With Surgery in Advanced Gastrointestinal Stromal Tumors That Have Failed Imatinib Therapy: A Multicenter,Observational Study

Conditions
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Gastrointestinal Stromal Tumor(GIST)

Intervention / Treatment
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* Procedure: Resection surgery of gastrointestinal stromal tumor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgery after ripretinib treatment<br>For subjects who achieved PR or SD, perform resection of gastrointestinal stromal tumor | Procedure: Resection surgery of gastrointestinal stromal tumor<br>* oral administration of Ripretinib 150 mg QD. Resection of gastrointestinal stromal tumors was performed in patients who achieved PR or SD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year Progression free survival rate | PFS Based on radiographic assessment using Choi criteria | 12 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate（ORR） | Objective response rate as determined by confirmed CR + confirmed PR by radiologic review | 12 monthes | 
| R0 resection rate | R0 is the proportion of subjects with no microscopic residual after resection | 1 days after surgery | 
| 2-year overall survival rate | Proportion of subjects with an overall survival time of at least 2 years | 24 monthes | 
| time to progression (TTP) | The time from the start of treatment to the progression | 12 monthes | 
| Duration of continuous medication before surgery | Only for subjects undergoing surgery | 12 monthes |