Combining radiotherapy with ripretinib for advanced GIST treatment
A Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST
This study is testing if combining radiotherapy with ripretinib can help people with advanced GIST live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Drugs / interventions | ripretinib |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06507683 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to evaluate the effectiveness and safety of combining radiotherapy with ripretinib in patients with unresectable advanced gastrointestinal stromal tumors (GIST). The research focuses on whether this combination can prolong the time to disease progression, as ripretinib is currently the standard fourth-line treatment but has limited efficacy. The study utilizes advanced radiotherapy techniques to optimize treatment delivery, potentially improving patient outcomes. By exploring this novel approach, the study seeks to enhance the chances of surgery and improve the quality of life for patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with unresectable advanced GIST who have progressed after multiple lines of treatment.
Not a fit: Patients with a life expectancy of less than three months or those who have previously received radiotherapy to the proposed site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly extend the time patients with advanced GIST can live without disease progression.
How similar studies have performed: While GIST was previously thought to be insensitive to radiotherapy, emerging studies suggest that this combination approach may be effective, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chongqing, Chongqing Municipality
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jun Zhang — First Affiliated Hospital of Chongqing Medical University
- Study coordinator: Jun Zhang, MD
- Email: zjun2323@sina.cn
- Phone: +86 136 1766 6067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.