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

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05354388
Collaborator
(none)
30
Enrollment
1
Location
26.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Resection surgery of gastrointestinal stromal tumor

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Ripretinib Combined With Surgery in Advanced Gastrointestinal Stromal Tumors That Have Failed Imatinib Therapy: A Multicenter,Observational Study
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
surgery after ripretinib treatment

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

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

Outcome Measures

Primary Outcome Measures

  1. 1-year Progression free survival rate [12 monthes]

    PFS Based on radiographic assessment using Choi criteria

Secondary Outcome Measures

  1. objective response rate（ORR） [12 monthes]

    Objective response rate as determined by confirmed CR + confirmed PR by radiologic review

  2. R0 resection rate [1 days after surgery]

    R0 is the proportion of subjects with no microscopic residual after resection

  3. 2-year overall survival rate [24 monthes]

    Proportion of subjects with an overall survival time of at least 2 years

  4. time to progression (TTP) [12 monthes]

    The time from the start of treatment to the progression

  5. Duration of continuous medication before surgery [12 monthes]

    Only for subjects undergoing surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sichuan Provincial People's Hospital Chengdu Sichuan China 610072

Sponsors and Collaborators

  • Sichuan Provincial People's Hospital

Investigators

  • Principal Investigator: Minghui Pang, Professor, Sichuan Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Minghui Pang, Professor, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier:
NCT05354388
Other Study ID Numbers:
  • 20211013
First Posted:
Apr 29, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors

Study Results

No Results Posted as of Apr 29, 2022