Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST

July 12, 2024 updated by: Jun Zhang, First Affiliated Hospital of Chongqing Medical University

A Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST

The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST. It will also learn about the safety of this regimen.The main questions it aim to answer is: Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

ripretinib is the standard fourth-line treatment agent for inoperable advanced GIST patients, but the mPFS is only 6.3 months. Prolonging the time to TKI resistance by using a new treatment approach is important to increase the chances of surgery ,improve the survival time, and quality of life for patients. GIST was previously thought to be a tumor that was insensitive to radiotherapy, but a growing number of studies have shown that GIST is moderately sensitive to radiotherapy and that radiotherapy is effective in controlling the tumor. In our previous work, palliative radiotherapy was given to patients with advanced GIST after multiline drug resistance, and we achieved local control for nearly 2 years while significantly improving the patient's symptoms .

In recent years, radiotherapy technology has been continuously improved, and new radiotherapy techniques can be more precise and have less impact on surrounding organs, making it possible to increase the dose of radiotherapy. For large GIST, our research team has optimized the radiotherapy technique by using simultaneous integrated boost intensity-modulated radiotherapy technique, which can deliver a safe dose at the edge of the tumor while delivering a high dose of radiotherapy at the center of the tumor, ensuring safety and resulting in better therapeutic effects.

We proposed to select some patients with unresectable advanced GIST to explore the feasibility of radiotherapy combined with TKI for the treatment of advanced GIST after failure of first-, second-, and third-line drug therapies with simultaneous addition of radiotherapy to oral ripretinib treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

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 Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary participation and signed informed consent;
  • age: 18 to 75 years, Male or female
  • Patients with histologically confirmed GIST and Imaging evaluated as unresectable recurrent and metastatic disease or locally advanced.
  • ECOG Performance Score: 0-2
  • Subjects who have progressed or documented intolerance after previous first-line, second-line, and third-line treatments.
  • At least one measurable lesion in the abdominal or pelvic cavity that has progressed after frontline treatment
  • Adequate organ function and bone marrow reserve

Exclusion Criteria:

  • estimated life-expectancy less than 3 months.
  • Patients who have received previous radiotherapy to the proposed radiotherapy site, or the tumor has significant mobility, poor tolerance of radiotherapy in adjacent organs, and who are considered unsuitable for radiotherapy after MDT discussion
  • Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
  • If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy combined with ripretinib group
Radiotherapy (50-70Gy/25-30f)+ ripretinib(150mg QD)
Radiation: simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib

A cumulative radiation dose of 50 to 70 Gy is administered in 25-30 fractions, 5 fractions per week, to the target lesion(s).

ripretinib: oral 150mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to disease progression of irradiated lesions
Time Frame: Approximately 12 months since the first subject enrolled
Time from start of radiotherapy to progression of irradiated lesions
Approximately 12 months since the first subject enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to disease progression of any lesions
Time Frame: Approximately 12 months since the first subject enrolled
Time from start of radiotherapy to progression of any lesions
Approximately 12 months since the first subject enrolled
Overall survival (OS)
Time Frame: Approximately 12 months since the first subject enrolled
the time from start of radiotherapy to all-cause death.
Approximately 12 months since the first subject enrolled
Objective Response Rate(ORR) of irradiated lesions
Time Frame: Approximately 12 months since the first subject enrolled
the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) based on mRECIST 1.1
Approximately 12 months since the first subject enrolled

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Chongqing Medical University

Collaborators

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Jun Zhang, First Affiliated Hospital of Chongqing Medical University

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)

May 28, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0 /2024.05.01

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.

Clinical Trials on Gastrointestinal Stromal Tumors

Clinical Trials on simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe