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Trial Title: Ripretinib in Chinese Patients With Advanced GIST: a Real World Study

NCT ID: NCT05697107

Condition: Gastrointestinal Stromal Tumors

Conditions: Official terms:
Gastrointestinal Stromal Tumors

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Ripretinib Oral Tablet
Description: Oral kinase inhibitor

Summary: to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world

Detailed description: Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.

Criteria for eligibility:

Study pop:
Histologically confirmed gastrointestinal stromal tumor

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: -≥18 years old - Histologically confirmed gastrointestinal stromal tumor (GIST) - At least one measurable lesion (mRECIST v1.1) - Received or receiving ripretinib treatment Exclusion Criteria: - Patients who received <1 cycle of ripretinib treatment - Medical records are incomplete

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Start date: May 20, 2021

Completion date: December 30, 2023

Lead sponsor:
Agency: Peking University
Agency class: Other

Collaborator:
Agency: First Affiliated Hospital, Sun Yat-Sen University
Agency class: Other

Collaborator:
Agency: Wuhan Union Hospital, China
Agency class: Other

Collaborator:
Agency: Sun Yat-sen University
Agency class: Other

Collaborator:
Agency: Fudan University
Agency class: Other

Collaborator:
Agency: Xiangya Hospital of Central South University
Agency class: Other

Collaborator:
Agency: Fujian Medical University Union Hospital
Agency class: Other

Collaborator:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Collaborator:
Agency: First Affiliated Hospital of Zhejiang University
Agency class: Other

Collaborator:
Agency: First Affiliated Hospital of Chongqing Medical University
Agency class: Other

Collaborator:
Agency: RenJi Hospital
Agency class: Other

Source: Peking University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05697107

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