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NCT04832776 Clinical Trial

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

Liver Metastasis Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04832776
Other study ID # Cetu-Bev-FOLFOXIRI
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 17, 2021
Est. completion date December 31, 2025

Study information
Verified date April 2021
Source Fudan University
Contact Wenhua Li
Phone 13817922257
Email whliiris@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 160
Est. completion date December 31, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cetuximab
one group plus cetuximab
• Bevacizumab
one group plus bevacizumab
• FOLFOXIRI
FOLFOXIRI

Locations
Country Name City State
China Department of Colorectal Surgery Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary ORR objective response rate up to 8 weeks
Secondary R0 resection rate of liver metastases R0 resection rate of liver metastases up to 8 weeks
Secondary NED rate percentage of patients who reach NED up to 8 weeks
Secondary OS overal survival up to 6 months
Secondary PFS progression free survival up to 8 weeks
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