Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

Sponsor
Peking University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04431791
Collaborator
(none)
268
1
20.3
13.2

Study Details

Study Description

Brief Summary

This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
268 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
A Single-center,Observational,Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies
Actual Study Start Date :
May 25, 2020
Anticipated Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Regorafenib

Drug: Regorafenib
oral regorafenib

Fruquintinib

Drug: Fruquintinib
oral fruquintinib

Outcome Measures

Primary Outcome Measures

  1. Time To Treatment Failure [every month, up to discontinuation of treatment for any reason.]

    the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

Secondary Outcome Measures

  1. Overall survival [from enrollment of the first subject until the database cut-off approximately 6 months later.]

    the time from first dose to the death for any cause.

  2. Progression-free survival [from enrollment of the first subject until the database cut-off approximately 6 months later.]

    the time from first dose to disease progression.

  3. Incidence of adverse events(AEs) [from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.]

    percentage of patients with AEs according to CTCAE 4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. signed and dated informed consent.

  2. Diagnosis of histologically confirmed colorectal cancer, stage IV.

  3. after second-line therapy.

  4. gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.

Exclusion Criteria:
  1. received regorafenib or fruquintinib before third-line therapy.

  2. the clinicopathological characteristics and previous therapy were unknown.

  3. regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking University
ClinicalTrials.gov Identifier:
NCT04431791
Other Study ID Numbers:
  • Reg vs Fru
First Posted:
Jun 16, 2020
Last Update Posted:
Jun 16, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2020