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

• Conditions: Gastrointestinal Stromal Tumor(GIST)
• Interventions: Procedure: Resection surgery of gastrointestinal stromal tumor

• Registration Number: NCT05354388
• Lead Sponsor: Sichuan Provincial People's Hospital

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 imatinib therapy.

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. 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

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Last Update Submitted: 2022-04-25
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
2. 18 years ≤ age < 75 years, male or female;
3. Histopathological examination confirmed the diagnosis of recurrent and/or metastatic advanced unresectable gastrointestinal stromal tumor;
4. According to the modified RECISTv1.1-GIST-specific criteria, the subject has at least one measurable lesion;
5. Subjects must have progressed on imatinib or have documented intolerance to imatinib.
6. ECOG PS of ≤ 2, ASA score ≤ 3 at screening;
7. No other malignant tumors occurred within five years;

Exclusion Criteria

1. Molecular pathology report PDGFRA Exon 18 mutation(including D842v);
2. 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;
3. Pregnant or lactating women;
4. 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.
5. Subject has known active central nervous system metastases.
6. Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
7. The patient has participated in or is participating in other clinical studies , or is taking other TKI agents;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgery after ripretinib treatment	Resection surgery of gastrointestinal stromal tumor	For subjects who achieved PR or SD, perform resection of gastrointestinal stromal tumor

Primary Outcome Measures

Name	Time	Method
1-year Progression free survival rate	12 monthes	PFS Based on radiographic assessment using Choi criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China