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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
