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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    30
  • sponsor
    Sichuan Provincial People's Hospital
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Updated on 14 May 2022
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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.

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

Details
Condition Gastrointestinal Stromal Tumor(GIST)
Treatment Resection surgery of gastrointestinal stromal tumor
Clinical Study IdentifierNCT05354388
SponsorSichuan Provincial People's Hospital
Last Modified on14 May 2022

Eligibility

 Yes No Not Sure

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
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