A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors

NCT05464875 · tracked via the Priya Life Science China tracker

Sponsor

Xinhua Zhang, MD

Phase

Observational

Started

2022-07-09

Last updated

2025-02-26

Condition(s) studied

Gastrointestinal Stromal TumorsUnresectable Solid TumorRecurrent Metastatic Malignant Neoplasm

Study summary

This is a prospective, multicenter, observational real-world study to explore the therapy patterns and clinical outcomes of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients who are aged ≥ 18 years. * Gastrointestinal stromal tumors confirmed by histopathological examination, and CD- and/or DOG-1-positive by immunohistochemistry. * Presence of mRECIST v1.1-compliant lesions with at least one measurable lesion (non-lymphadenopathy ≥1.0 cm or ≥2-fold scan slice thickness). * Treatment with Avapritinib. * Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening. * Patient informed consent and signed written consent form. * The patient was compliant and voluntarily scheduled for follow-up, treatment, laboratory tests, and other study procedures. Exclusion Criteria: * KIT or PDGFRA wild type. * Failure to complete continuous atorvastatin for at least 15 days due to intolerability or disease progression. * Other serious acute or chronic physical or mental problems, or laboratory abnormalities, may increase the risk associated with participation in the study or use of drugs, or interfere with the judgment of the study results and, in the judgment of the investigator, are not considered appropriate for participation in the investigator.

Primary outcome measure(s)

Objective Response Rate — 2 years
To evaluate objective response rate (ORR,CR+PR) determined by radiology assessment per mRECIST(Response Evaluation Criteriain Solid Tumours), version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.
Clinical Benefit Rate — 2 years
To evaluate clinical benefit rate(CBR,CR+PR+\>16 weeks continuation SD) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.
Duration Of Response — 2 years
To evaluate duration of response (DOR) determined by radiology assessment per mRECIST, version 1.1 in patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors.Complete response is the disappearance of all lesions with nodes measuring \< 10 mm and normal tumour markers.A decrease in the sum of target disease of ≥ 30% represents partial response.Stable disease lies between partial response and progressive disease.If a lesion reappears after disappearing in a patient with complete response, progressive disease is declared. However, if such a lesion behaves in this manner in a patient with stable disease or partial response, it is the change in sum of target disease that defines the response or progression.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	China	Recruiting

More Xinhua Zhang, MD trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05464875 on ClinicalTrials.gov ↗ ← All trials in China