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

April 25, 2022 updated by: Minghui Pang, Sichuan Provincial People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Minghui Pang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients enrolled in this study will be outpatients from Sichuan Provincial People's Hospital and cooperative hospitals

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year Progression free survival rate
Time Frame: 12 monthes
PFS Based on radiographic assessment using Choi criteria
12 monthes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate（ORR）
Time Frame: 12 monthes
Objective response rate as determined by confirmed CR + confirmed PR by radiologic review
12 monthes
R0 resection rate
Time Frame: 1 days after surgery
R0 is the proportion of subjects with no microscopic residual after resection
1 days after surgery
2-year overall survival rate
Time Frame: 24 monthes
Proportion of subjects with an overall survival time of at least 2 years
24 monthes
time to progression (TTP)
Time Frame: 12 monthes
The time from the start of treatment to the progression
12 monthes
Duration of continuous medication before surgery
Time Frame: 12 monthes
Only for subjects undergoing surgery
12 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20211013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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