The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis of RAS wildtype. The patients will be treated in two therapy groups: Experimental arm A: Chemotherapy with FOLFOXIRI + Cetuximab Standard arm B: Chemotherapy with FOLFOX + Cetuximab
We intend to carry out a randomized controlled clinical study of cetuximab plus FOLFOXIRI regimen versus cetuximab plus FOLFOX regimen in the first-line treatment of patients with initially unresectable CRLM, to answer the question of whether cetuximab plus FOLFOXIRI regimen can improve the overall ORR, surgical resection rate and OS compared with cetuximab plus FOLFOX regimen in patients with previously untreated, initially unresectable CRLM patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Irinotecan 130 mg/m²
Cetuximab, iv, 500mg/m2
5-FU 2400 mg/m² cont. inf.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Overall Response Rate
Partial response (PR) plus complete response (CR)): assessed by the investigator using RECIST v1.1 criteria
Time frame: assessed up to 12 months
Depth of Response
The investigator assesses DpR by measuring the ratio of maximum tumor regression to baseline tumor, and calculates the median value
Time frame: Each follow up visit, assessed up to 12 months
R0 Resection Rate
Defined as the proportion of patients who achieve complete resection after treatment with cetuximab plus FOLFOXIRI regimen or cetuximab plus FOLFOX regimen according to the study protocol
Time frame: Each follow up visit, assessed up to 12 months
Early Tumor Shrinkage
Target lesion reduction of a least 20% from the nadir following 4 treatment courses assessed using the RECIST version 1.1 criteria
Time frame: Each follow up visit, assessed up to 12 months
Progression-Free Survival
Assessed by the investigator using RECIST v1.1, defined as the time from the start of study treatment to disease progression, or relapse after resection of liver metastases, or death due to any cause.
Time frame: Each follow up visit, assessed up to 60 months
Overall Survival
Defined as the time from the start of study treatment to death due to any cause
Time frame: Each follow up visit, assessed up to 60 months
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oxaliplatin 85 mg/m²
leucovorin 200 mg/m²