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Trial record 180 of 350 for:    Gastrointestinal Stromal Tumors
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Ripretinib in Chinese Patients With Advanced GIST: a Real World Study

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ClinicalTrials.gov Identifier: NCT05697107
Recruitment Status : Active, not recruiting
First Posted : January 25, 2023
Last Update Posted : January 25, 2023
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
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
Information provided by (Responsible Party):
Shen Lin, Peking University

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

Condition or disease Intervention/treatment
Gastrointestinal Stromal Tumors Drug: Ripretinib Oral Tablet

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.
Study Design
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Study Type : Observational
Actual Enrollment : 308 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Large Scale, Multicenter, Real-World Study on Patients With Advanced GIST Receiving Ripretinib
Actual Study Start Date : May 20, 2021
Actual Primary Completion Date : August 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ripretinib

Groups and Cohorts
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Intervention Details:
  • Drug: Ripretinib Oral Tablet
    Oral kinase inhibitor

Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: approximately 7 months ]
    To assess the efficacy (progression-free survival [PFS]


Secondary Outcome Measures :
  1. DCR [ Time Frame: approximately 6 months ]
    To assess disease control rate (DCR)

  2. OS [ Time Frame: approximately 12 months ]
    to assess median overall survival (mOS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Histologically confirmed gastrointestinal stromal tumor
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05697107


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
First Affiliated Hospital, Sun Yat-Sen University
Wuhan Union Hospital, China
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
Investigators
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Principal Investigator: Lin Shen, MD Peking University
More Information
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Responsible Party: Shen Lin, Director of GI oncology Affiliation: Peking University, Peking University, Peking University
ClinicalTrials.gov Identifier: NCT05697107    
Other Study ID Numbers: GIST-R-RWD-001
First Posted: January 25, 2023    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: UNDECIDED

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases