Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

Launched by XINHUA ZHANG, MD · Jun 27, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well different second-line treatments work for patients with advanced gastrointestinal stromal tumors (GIST) who haven't responded well to their first treatment. The study aims to gather real-world information on the types of medications used after the initial treatment and the outcomes for the patients. It's currently recruiting participants who are 18 years or older and have been diagnosed with metastatic or unresectable GIST, meaning their cancer has spread and cannot be surgically removed. To qualify, patients must have received a specific initial treatment called imatinib or another similar drug and show that their disease has worsened or they couldn’t tolerate the treatment.

If you or someone you know is interested in participating, you should be in good overall health (with a performance status score of 0 to 2, which means you can carry out normal activities with some limitations). Participants can expect to receive one of several approved second-line treatments, such as sunitinib or ripretinib, and will be monitored closely throughout the study. It's important to note that individuals who have received two or more previous treatments, have a life expectancy of less than three months, or are pregnant or breastfeeding cannot join the trial. This study aims to help improve care for future patients with GIST by understanding how different treatments work in everyday settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who are aged ≥ 18 years.
• • Patients who have histologically confirmed metastatic or unresectable GIST.
• • Patients who received imatinib at a fixed dose or 1 other TKI as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression before enrollment.
• • Patients must have at least a measurable lesion according to mRECIST Version 1.1.
• • According to the current GIST national guidelines, patients who receive second-line treatments, including but not limited to sunitinib, imatinib dose escalation, ripretinib, dasatinib, and other drug treatments.
• • Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.
• Exclusion Criteria:
• • Patients who previously received two or more TKIs as prior treatment regimens.
• • Patients with a life expectancy of fewer than three months.
• • Patients who are pregnant and lactating.
• • Patients with an estimated poor adherence or inability to complete follow-up.
• • Patients who are not appropriate to enroll due to the investigator's consideration.