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

RECRUITINGSponsored by Xinhua Zhang, MD
Actively Recruiting
SponsorXinhua Zhang, MD
Started2022-07-01
Est. completion2025-09-30
Eligibility
Age18 Years+
Healthy vol.Accepted

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 first-line anticancer treatment.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

CancerGastrointestinal Stromal Tumors

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