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RecruitingNCT05440357

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

Sponsor

Xinhua Zhang, MD

Enrollment

100 participants

Start Date

Jul 1, 2022

Study Type

OBSERVATIONAL

Conditions

Gastrointestinal Stromal Tumors

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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Locations(8)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The first affiliated hospital,Sun yat-sen university

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Hainan Cancer Hospital

Haikou, Hannan, China

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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