Back to resultsFOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
Primary Purpose
Liver Metastasis Colon Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cetuximab
Bevacizumab
FOLFOXIRI
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastasis Colon Cancer focused on measuring FOLFOXIRI, cetuximab, bevacizumab
Eligibility Criteria
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
Sites / Locations
- Department of Colorectal Surgery Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FOLFOXIRI+C225
FOLFOXIRI+BEV
Arm Description
Outcomes
Primary Outcome Measures
ORR
objective response rate
Secondary Outcome Measures
R0 resection rate of liver metastases
R0 resection rate of liver metastases
NED rate
percentage of patients who reach NED
OS
overal survival
PFS
progression free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04832776
Brief Title
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
Official Title
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2021 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis Colon Cancer
Keywords
FOLFOXIRI, cetuximab, bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFOXIRI+C225
Arm Type
Experimental
Arm Title
FOLFOXIRI+BEV
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
one group plus cetuximab
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
one group plus bevacizumab
Intervention Type
Drug
Intervention Name(s)
FOLFOXIRI
Intervention Description
FOLFOXIRI
Primary Outcome Measure Information:
Title
ORR
Description
objective response rate
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
R0 resection rate of liver metastases
Description
R0 resection rate of liver metastases
Time Frame
up to 8 weeks
Title
NED rate
Description
percentage of patients who reach NED
Time Frame
up to 8 weeks
Title
OS
Description
overal survival
Time Frame
up to 6 months
Title
PFS
Description
progression free survival
Time Frame
up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhua Li
Phone
13817922257
Ext
13817922257
Email
whliiris@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Zhang
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Colorectal Surgery Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjun Cai, M.D
Phone
+86-21-64175590
Ext
81108
Email
caisanjuncsj@163.com
12. IPD Sharing Statement
Learn more about this trial
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases
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