RecruitingPhase 3NCT05862337

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).

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

480 participants

Start Date

May 10, 2023

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether anlotinib (an anti-blood vessel drug) combined with penpulimab (an immunotherapy) can reduce the chance of liver cancer returning in people who have had their tumor completely removed or destroyed but are at high risk of recurrence. **You may be eligible if...** - You are between 18 and 75 years old - You have hepatocellular carcinoma (the most common type of liver cancer) - Your liver tumor was completely removed by surgery or destroyed by ablation (radiofrequency or microwave) within the past 4–12 weeks - You have risk factors that suggest your cancer is likely to come back - Your recovery from surgery or ablation is complete and your cancer shows no signs of returning at the start of the study **You may NOT be eligible if...** - Your tumor is a rare or mixed type (e.g., fibrolamellar or mixed cholangiocarcinoma) - There is still evidence of cancer remaining after treatment - You have already had more than one surgery for liver cancer - You have previously used anti-angiogenic drugs or immunotherapy (PD-1/PD-L1 drugs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib 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).

DRUGAnlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo

placebo control, no active substance.

Locations(67)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking Union Medical College Hospital