FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases

April 5, 2021 updated by: Sanjun Cai, Fudan University
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

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
        • Department of Colorectal Surgery Fudan University Shanghai Cancer Center
        • 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ECOG perfomance 0-1
  • pathologically confirmed colorectal carcinoma, with RAS wild type
  • inital unresectable liver metastases discussed by MDT
  • prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
  • without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
  • adequate blood, liver and renal function
  • expected survival longer than 6 months

Exclusion Criteria:

  • with bleeding risk
  • interestinal obstruction or disease
  • uncontrolled hypertension and severe heart disease
  • previous severe thrombotic events
  • central nervous system metastases
  • accompanied with other malignant tumor

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FOLFOXIRI+C225
Drug: Cetuximab
one group plus cetuximab
Drug: FOLFOXIRI
FOLFOXIRI
Active Comparator: FOLFOXIRI+BEV
Drug: FOLFOXIRI
FOLFOXIRI
Drug: Bevacizumab
one group plus bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 8 weeks
objective response rate
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate of liver metastases
Time Frame: up to 8 weeks
R0 resection rate of liver metastases
up to 8 weeks
NED rate
Time Frame: up to 8 weeks
percentage of patients who reach NED
up to 8 weeks
OS
Time Frame: up to 6 months
overal survival
up to 6 months
PFS
Time Frame: up to 8 weeks
progression free survival
up to 8 weeks

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Wen Zhang, 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 (Anticipated)

April 17, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cetu-Bev-FOLFOXIRI

Drug and device information, study documents

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.

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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