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

NCT ID: NCT04832776

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-17

Study Completion Date

2025-12-31

Brief Summary

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To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases

Detailed Description

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Conditions

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Liver Metastasis Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFOXIRI+C225

Group Type EXPERIMENTAL

Cetuximab

Intervention Type DRUG

one group plus cetuximab

FOLFOXIRI

Intervention Type DRUG

FOLFOXIRI

FOLFOXIRI+BEV

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

one group plus bevacizumab

FOLFOXIRI

Intervention Type DRUG

FOLFOXIRI

Interventions

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Cetuximab

one group plus cetuximab

Intervention Type DRUG

Bevacizumab

one group plus bevacizumab

Intervention Type DRUG

FOLFOXIRI

FOLFOXIRI

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Sanjun Cai

Department of Colorectal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen Zhang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Department of Colorectal Surgery Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhua Li

Role: CONTACT

13817922257 ext. 13817922257

Facility Contacts

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Sanjun Cai, M.D

Role: primary

+86-21-64175590 ext. 81108

Other Identifiers

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Cetu-Bev-FOLFOXIRI

Identifier Type: -

Identifier Source: org_study_id

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