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

Sichuan Provincial People's Hospital

Status: Unknown

Conditions: Gastrointestinal Stromal Tumor(GIST)

Treatments: Procedure: Resection surgery of gastrointestinal stromal tumor

Study type: Observational

Funder types: Other

Identifiers

NCT05354388

20211013

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

30 participants in 1 patient group

surgery after ripretinib treatment

Description:

For subjects who achieved PR or SD, perform resection of gastrointestinal stromal tumor

Treatment:

Procedure: Resection surgery of gastrointestinal stromal tumor