Gastrointestinal Stromal Tumors
Conditions
Brief 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.
Interventions
DRUGRipretinib Oral Tablet
Oral kinase inhibitor
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sun Yat-sen University
Fudan University
Xiangya Hospital of Central South University
Fujian Medical University Union Hospital
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Chongqing Medical University
RenJi Hospital
Peking University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | approximately 7 months | To assess the efficacy (progression-free survival \[PFS\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | approximately 6 months | To assess disease control rate (DCR) |
| OS | approximately 12 months | to assess median overall survival (mOS) |
Countries
China
Outcome results
None listed