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.
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 Type
OBSERVATIONAL
Enrollment
30
oral administration of Ripretinib 150 mg QD. Resection of gastrointestinal stromal tumors was performed in patients who achieved PR or SD
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
RECRUITING1-year Progression free survival rate
PFS Based on radiographic assessment using Choi criteria
Time frame: 12 monthes
objective response rate(ORR)
Objective response rate as determined by confirmed CR + confirmed PR by radiologic review
Time frame: 12 monthes
R0 resection rate
R0 is the proportion of subjects with no microscopic residual after resection
Time frame: 1 days after surgery
2-year overall survival rate
Proportion of subjects with an overall survival time of at least 2 years
Time frame: 24 monthes
time to progression (TTP)
The time from the start of treatment to the progression
Time frame: 12 monthes
Duration of continuous medication before surgery
Only for subjects undergoing surgery
Time frame: 12 monthes
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