Exploring second-line treatments for advanced gastrointestinal stromal tumors
Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study
This study is trying to see how well different second-line treatments work for people with advanced gastrointestinal stromal tumors who didn't respond to or couldn't tolerate their first treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | imatinib, sunitinib, ripretinib, dasatinib, repritinib |
| Locations | 8 sites (Chongqing, Chongqing Municipality and 7 other locations) |
| Trial ID | NCT05440357 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the patterns of second-line pharmacotherapy and clinical outcomes in patients with advanced gastrointestinal stromal tumors (GIST) who have either progressed on or are intolerant to first-line treatment with imatinib. The study will collect real-world data from multiple centers to better understand the effectiveness of various second-line therapies, including sunitinib and other tyrosine kinase inhibitors. By focusing on patients with measurable lesions and specific treatment histories, the study seeks to provide insights into optimal treatment strategies for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed metastatic or unresectable GIST who have previously received imatinib and experienced disease progression.
Not a fit: Patients who have received two or more tyrosine kinase inhibitors or have a life expectancy of fewer than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify more effective second-line treatment options for patients with advanced GIST, potentially improving their outcomes.
How similar studies have performed: Previous studies have shown varying degrees of success with second-line treatments for GIST, but this study aims to provide new insights into real-world treatment patterns and outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing, Chongqing Municipality and 7 other locations
- Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
- Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- The first affiliated hospital,Sun yat-sen university — Guangzhou, Guangdong, China (Recruiting)
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
- Hainan Cancer Hospital — Haikou, Hannan, China (Recruiting)
- Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Principal investigator: zhang xinhua, PhD — First affiliated hosptial,Sun Yat-sen university
- Study coordinator: zhang xinhua, PhD
- Email: zhangxinhua@mail.sysu.edu.cn
- Phone: +8620-87332200
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.