NCT05354388

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastrointestinal Stromal Tumor(GIST)

Interventions

Type	Name	Description
PROCEDURE	Resection surgery of gastrointestinal stromal tumor	oral administration of Ripretinib 150 mg QD. Resection of gastrointestinal stromal tumors was performed in patients who achieved PR or SD

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: China