A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

Summary

This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.

Timeline

Start

2020-08-11

Primary completion

2026-12

Completion

2026-12

Publications

• Zhou J, Bai L, Luo J, Bai Y, Pan Y, Yang X, Gao Y, Shi R, Zhang W, Zheng J, Hua X, Xu A, Hu S, Zhang F, Yang X, Da M, Wang R, Ma J, Jia W, Quan D, Peng C, Yang W, Yin G, Qi Y, Zhang G, Du X, Mao X, Meng Z, Jiao S, Fan J; APOLLO Study Group. Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO): a randomised, controlled, phase 3 trial. Lancet Oncol. 2025 Jun;26(6):719-731. doi: 10.1016/S1470-2045(25)00190-1. Epub 2025 May 8.

Drugs

Indications