Status:
RECRUITING
Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study
Lead Sponsor:
Xinhua Zhang, MD
Collaborating Sponsors:
Guangdong Provincial People's Hospital
Nanfang Hospital, Southern Medical University
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicenter, observational real-world study to explore the second-line Pharmacotherapy patterns and clinical outcomes in GIST patients who progressed on or were intolerant to fi...
Detailed Description
INTRODUCTION AND RATIONALE Gastrointestinal stromal tumors (GIST) are thought to develop from the interstitial cells of Cajal or their stem cell precursors. They are the most common mesenchymal tumors...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05440357
Start Date
July 1 2022
End Date
September 30 2025
Last Update
February 26 2025
Active Locations (8)
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1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
2
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510014
3
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
4
The first affiliated hospital,Sun yat-sen university
Guangzhou, Guangdong, China