A Trial of Licartin for Preventing Tumor Recurrence After Liver Resection

NCT00819650 ↗

Phase 2 Completed 200 enrolled Eastern Hepatobiliary Surgery Hospital

RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to analyze the therapeutic effect of adjuvant Licartin therapy after resection.Patients receiving curative resection (R0) were randomized to postoperative Licartin group and no Licartin group. The time to recurrence ,the overall survival as well as the incidence of complications after therapy was observed to confirm the role of adjuvant therapy of Licartin.

Timeline

Start: 2008-12
Primary completion: 2009-12
Completion: 2010-12

Outcome

Met primary endpoint

paper the 5-year RFS was 43·4% (95% CI 33·6-55·9) in the 131I-metuximab group and 21·7% (14·2-33·1) in the control group PMID 32164877 ↗

paper hazard ratio 0·49 [95% CI 0·34-0·72]; Z=2·96, p=0·0031 PMID 32164877 ↗

Publications

Li J, Xing J, Yang Y, Liu J, Wang W, Xia Y, Yan Z, Wang K, Wu D, Wu L, Wan X, Yang T, Gao C, Si A, Wang H, Wu M, Lau WY, Chen Z, Shen F. Adjuvant 131I-metuximab for hepatocellular carcinoma after liver resection: a randomised, controlled, multicentre, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):548-560. doi: 10.1016/S2468-1253(19)30422-4. Epub 2020 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IODINE (131I) METUXIMAB	Monoclonal antibody	27.75 mbq/kg	Other