FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
1 other identifier
interventional
160
1 country
1
Brief Summary
To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedStudy Start
First participant enrolled
April 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 6, 2021
April 1, 2021
2.7 years
April 2, 2021
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ORR
objective response rate
up to 8 weeks
Secondary Outcomes (4)
R0 resection rate of liver metastases
up to 8 weeks
NED rate
up to 8 weeks
OS
up to 6 months
PFS
up to 8 weeks
Study Arms (2)
FOLFOXIRI+C225
EXPERIMENTALFOLFOXIRI+BEV
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Department of Colorectal Surgery Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen Zhang
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Colorectal Surgery
Study Record Dates
First Submitted
April 2, 2021
First Posted
April 6, 2021
Study Start
April 17, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2025
Last Updated
April 6, 2021
Record last verified: 2021-04