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

NCT ID: NCT05697107

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Ripretinib Oral Tablet

Oral kinase inhibitor

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

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Shen Lin

Director of GI oncology Affiliation: Peking University, Peking University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Zhang X, Zhang P, Qiu H, Fang Y, Liu H, Zhou Y, Xu H, Yu J, Zhang J, Wang M, Shen L, Li J. Large-Scale, Multicenter, Prospective Registry Study of Ripretinib in Advanced GIST: A Real-World Study from China. Adv Ther. 2023 Sep;40(9):3817-3829. doi: 10.1007/s12325-023-02576-0. Epub 2023 Jun 25.

Reference Type DERIVED
PMID: 37356078 (View on PubMed)

Other Identifiers

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GIST-R-RWD-001

Identifier Type: -

Identifier Source: org_study_id

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