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

Launched by FIRST AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY · Jul 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the combination of radiotherapy and a medication called ripretinib to see if this approach can help patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed. The main goal is to find out if this treatment can help delay the progression of the disease and to assess how safe this combination is for patients.

To participate in this trial, patients need to be between 18 and 75 years old and have a confirmed diagnosis of GIST that has come back or spread and cannot be treated with surgery. They should also have previously tried other treatments without success. Participants will receive the combined treatment and will be monitored for its effects. Importantly, patients who have serious health issues that could interfere with the study or who are pregnant or breastfeeding are not eligible to join. If you or a loved one is considering this trial, it could be a chance to access a new treatment approach while contributing to important research.

Gender

ALL

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