NCT04344158

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

A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 648 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	AK105 Injection	AK105 200mg intravenously (IV) on day 1 of each 21-day cycle.
DRUG	Anlotinib Hydrochloride Capsules	Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
DRUG	Sorafenib Tosylate Tablets	Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle.

Timeline

• Start date: 2020-08-11
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-04-14
• Last updated: 2025-02-20

Locations

81 sites across 1 country: China