Back to resultsConversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases
Primary Purpose
Colorectal Cancer, Liver Metastases
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cetuximab
Bevacizumab
mFOLFOX/FOLFIRI ( Standard Chemotherapy)
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Cetuximab, Bevacizumab, Liver Metastases, Colorectal Cancer, right-sided
Eligibility Criteria
Inclusion Criteria:
- The primary tumor was confirmed by histology as colorectal adenocarcinoma
- primary right-sided colorectal adenocarcinoma
- Radiologic evidence suggests that the initial unresectable liver metastases
- RAS/BRAF gene wild-type states
- ECOG was 0 ~ 1
- Life expectancy ≥ 3 months
- Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
- Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
- Sign the written informed consent to participate in the experiment
Exclusion Criteria:
- Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
- Known or suspected extrahepatic metastasis
- Patients with known hypersensitivity to any component of the study treatment
- Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
- Acute or subacute intestinal obstruction
- Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
- She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
- Known drug / alcohol abuse
- No legal capacity or limited legal capacity
- There is peripheral neuropathy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
standard chemotherapy plus Cetuximab
standard chemotherapy plus Bevacizumab
Arm Description
Outcomes
Primary Outcome Measures
Conversion liver resection rate
Rate of conversion from initially unresectable liver metastases to resectable ones
Secondary Outcome Measures
objective response rate
rate of objective response for therapy(according to RECIST 1.0)
Incidence of adverse events
Incidence of adverse events
Progression free survival
Progression free survival
overall survival
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04525326
Brief Title
Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases
Official Title
A Prospective Study on the Conversion Therapy of Ras / BRAF Wild Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases: Standard Chemotherapy Plus Cetuximab VS. Standard Chemotherapy Plus Bevacizumab
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
5. Study Description
Brief Summary
The prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. Different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. The United States NCCN guidelines do not recommend standard chemotherapy combined with anti EGFR monoclonal antibody for patients with right colon cancer. The European ESMO guidelines recommend that patients with Ras / BRAF wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti EGFR monoclonal antibody is still one of the choices. China CSCO guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer.
Therefore, the targeted therapy for RAS / BRAF wild-type metastatic right colon cancer is still controversial. Therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for RAS / BRAF wild-type metastatic right colon cancer. The conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastases
Keywords
Cetuximab, Bevacizumab, Liver Metastases, Colorectal Cancer, right-sided
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
584 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard chemotherapy plus Cetuximab
Arm Type
Experimental
Arm Title
standard chemotherapy plus Bevacizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
mFOLFOX+Cetuximab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
mFOLFOX+Bevacizumab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
Intervention Type
Drug
Intervention Name(s)
mFOLFOX/FOLFIRI ( Standard Chemotherapy)
Intervention Description
Standard Chemotherapy
Primary Outcome Measure Information:
Title
Conversion liver resection rate
Description
Rate of conversion from initially unresectable liver metastases to resectable ones
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
objective response rate
Description
rate of objective response for therapy(according to RECIST 1.0)
Time Frame
up to 6 months
Title
Incidence of adverse events
Description
Incidence of adverse events
Time Frame
up to 6 months
Title
Progression free survival
Description
Progression free survival
Time Frame
up to 3 years
Title
overall survival
Description
overall survival
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The primary tumor was confirmed by histology as colorectal adenocarcinoma
primary right-sided colorectal adenocarcinoma
Radiologic evidence suggests that the initial unresectable liver metastases
RAS/BRAF gene wild-type states
ECOG was 0 ~ 1
Life expectancy ≥ 3 months
Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization)
Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization);
Sign the written informed consent to participate in the experiment
Exclusion Criteria:
Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy
Known or suspected extrahepatic metastasis
Patients with known hypersensitivity to any component of the study treatment
Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range
Acute or subacute intestinal obstruction
Pregnancy (no pregnancy confirmed by serum / urine β - hCG) or breastfeeding.
She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer
Known drug / alcohol abuse
No legal capacity or limited legal capacity
There is peripheral neuropathy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Conversion Therapy of RAS/BRAF Wild-Type Right-sided Colon Cancer Patients With Initially Unresectable Liver Metastases
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