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

Outcome

Met primary endpoint

paper Anlotinib plus penpulimab significantly improved progression-free survival and overall survival versus sorafenib in unresectable HCC PMID 40349716 ↗

paper Median progression-free survival was significantly extended with anlotinib plus penpulimab versus sorafenib PMID 40349716 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Catequentinib	Small molecule	10 mg	Oral
Subject	Penpulimab	Monoclonal antibody	200 mg	Intravenous
Comparator	Sorafenib	Small molecule	400 mg	Oral

Indications