Cetuximab Plus FOLFOXIRI vs Cetuximab Plus FOLFOX For CRCLM

Phase 2 Active not recruiting 146 enrolled Sun Yat-sen University

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2018-04-15
Primary completion: 2022-12-30
Completion: 2026-06

Outcome

Missed primary endpoint

paper 84.7% versus 79.7% in the triplet and doublet arms, respectively (odds ratio [OR] 0.70; 95% confidence intervals [CI] [0.30, 1.67], Chi-square p = 0.42). PMID 38728364 ↗

paper The combination of cetuximab with FOLFOXIRI did not significantly improve ORR compared to cetuximab plus FOLFOX. PMID 38728364 ↗

Publications

Wang DS, Ren C, Li SS, Fong WP, Wu XJ, Xiao J, Li BK, Zheng Y, Ding PR, Chen G, Qiu MZ, Wang ZQ, Wang FH, Luo HY, Wang F, Wang XZ, Wang LY, Xie DJ, Chen T, Li LR, Lu ZH, Zhai XH, Liu TS, Yuan Y, Chen JQ, Tan Q, Pan ZZ, Wan DS, Zhang R, Yuan YF, Xu RH, Li YH. Cetuximab plus FOLFOXIRI versus cetuximab plus FOLFOX as conversion regimen in RAS/BRAF wild-type patients with initially unresectable colorectal liver metastases (TRICE trial): A randomized controlled trial. PLoS Med. 2024 May 10;21(5):e1004389. doi: 10.1371/journal.pmed.1004389. eCollection 2024 May.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	130 mg/m2	—
Background	Cetuximab	Monoclonal antibody	500 mg/m2	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	—