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

Sponsor
Peking University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05697107
Collaborator
First Affiliated Hospital, Sun Yat-Sen University (Other), Wuhan Union Hospital, China (Other), Sun Yat-sen University (Other), Fudan University (Other), Xiangya Hospital of Central South University (Other), Fujian Medical University Union Hospital (Other), The First Affiliated Hospital with Nanjing Medical University (Other), First Affiliated Hospital of Zhejiang University (Other), First Affiliated Hospital of Chongqing Medical University (Other), RenJi Hospital (Other)
308
Enrollment
1
Location
31.3
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

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 :
Aug 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Outcome Measures

Primary Outcome Measures

  1. PFS [approximately 7 months]

    To assess the efficacy (progression-free survival [PFS]

Secondary Outcome Measures

  1. DCR [approximately 6 months]

    To assess disease control rate (DCR)

  2. OS [approximately 12 months]

    to assess median overall survival (mOS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Lin Shen, MD, Peking University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:
Gastrointestinal Stromal Tumors

Study Results

No Results Posted as of Jan 25, 2023