Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

January 13, 2024 updated by: Xu jianmin, Fudan University

A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer

Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Principal Investigator:
          • Jianmin Xu
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with refractory metastatic colorectal cancer who have undergone third-line or later treatment with a combination of fruquintinib and TAS-102.

Description

Inclusion Criteria:

  • Histology-confirmed metastatic CRC (mCRC)
  • Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab
  • Fruquintinib administered as salvage treatment
  • Age: 18-75 years old
  • Informed consent

Exclusion Criteria:

  • Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy
  • Fruquintinib and/or TAS-102 administration as second-line treatment
  • Drug administration stopped after less than two cycles

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fru plus TAS-102
mCRC patients receiveing Fruquintinib combined with TAS-102 in third- or late- line
Drug: Fruquintinib Combined With TAS-102
Fruquintinib Combined With TAS-102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: 3 years
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death.
3 years
Overall Survival (OS)
Time Frame: 3 years
OS was defined as the time from fruquintinib administration to death.
3 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Jianmin Xu, Department of Colorectal Surgery, Zhongshan Hospital, Fudan 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)

January 1, 2020

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

December 27, 2023

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fru plus TAS-102 in mCRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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