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).

NCT05862337 Phase 3 RECRUITING

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).

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	480
Start date	2023-05-10
Completion	2026-12

Conditions

• Hepatocellular Carcinoma

Interventions

• Anlotinib hydrochloride capsules, Penpulimab injection
• Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo

Primary outcomes

• Recurrence-free survival (RFS) — Baseline up to 3 years.
  RFS assessed by the Blinded Independent Image Review Committee and the investigator is the time from randomization to the first local, regional recurrence or distant metastasis, or death from any cause, whichever occurred first.

Countries

China