Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

June 11, 2020 updated by: Shen Lin, Peking University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

268

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with signing the informed consent, would be enrolled when their gastrointestinal physician prescribed to receive regorafenib or fruquintinib after second-line according the condition.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Regorafenib
Drug: Regorafenib
oral regorafenib
Fruquintinib
Drug: Fruquintinib
oral fruquintinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Treatment Failure
Time Frame: 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.
every month, up to discontinuation of treatment for any reason.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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.
from enrollment of the first subject until the database cut-off approximately 6 months later.
Progression-free survival
Time Frame: from enrollment of the first subject until the database cut-off approximately 6 months later.
the time from first dose to disease progression.
from enrollment of the first subject until the database cut-off approximately 6 months later.
Incidence of adverse events（AEs）
Time Frame: 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
from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

June 6, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reg vs Fru

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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