NCT05862337

Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study of Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection in Patients With High Risk of Relapse After Radical Surgery or Ablation of Hepatocellular Carcinoma (HCC).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride capsules, Penpulimab injection	Anlotinib hydrochloride capsules is a multitargeted receptor tyrosine kinase inhibitor. Penpulimab injection is a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1).
DRUG	Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo	placebo control, no active substance.

Timeline

• Start date: 2023-05-10
• Primary completion: 2024-08-01
• Completion: 2026-12-01
• First posted: 2023-05-17
• Last updated: 2023-05-17

Locations

67 sites across 1 country: China