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

NCT ID: NCT06507683

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2027-07-31

Brief Summary

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?

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

Conditions

Gastrointestinal Stromal Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy combined with ripretinib group

Radiotherapy (50-70Gy/25-30f)+ ripretinib(150mg QD)

Group Type: EXPERIMENTAL

simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Zhang, MD

Role: CONTACT

zjun2323@sina.cn

+86 136 1766 6067

Longhao Li, MD

Role: CONTACT

llh@hospital.cqmu.edu.cn

+86 183 7580 7001

Facility Contacts

Jun Zhang, MD

Role: primary

zjun2323@sina.cn

+86 136 1766 6067

References

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Reference Type: BACKGROUND

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Other Identifiers

1.0 /2024.05.01

Identifier Type: -

Identifier Source: org_study_id