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Recruiting NCT05862337

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

Phase III Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anlotinib hydrochloride capsules, Penpulimab injection, Anlotinib hydrochloride capsules -matching placebo, Penpulimab injection -matching placebo.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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).

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Recurrence-free survival (RFS) [Time frame: Baseline up to 3 years.]
Secondary outcome measures (4)
  • Time to recurrence(TTR) [Time frame: Baseline up to 3 years.]
  • Time to extrahepatic metastasis or macrovascular invasion [Time frame: Baseline up to 3 years.]
  • Overall survival (OS) [Time frame: Baseline up to 3 years.]
  • Objective response rate (ORR) after first recurrence [Time frame: Baseline up to 3 years.]

Eligibility criteria

Inclusion criteria

  • Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1; Predicted survival ≥12 weeks.
  • Subjects with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or who meet the diagnostic criteria for Primary Liver Cancer 2022 or the American Association for the Study of Hepatology (AASLD) hepatocellular carcinoma.
  • Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) or Microwave Ablation (MWA) only) within 4 to 12 weeks prior to randomization (multiple modalities or combined or multiple treatments are not acceptable).
  • No major vena portae 3 (Vp3) or vena portae 4 (Vp4) in the portal vein or any level of vascular invasion in the hepatic vein or inferior vena cava.
  • No extrahepatic metastasis.
  • High risk factors for recurrence after radical resection or complete ablation.
  • Complete recovery from surgical resection or ablation within 4 weeks before randomization.

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology.
  • Evidence of residual, recurrent, or metastatic disease at randomization.
  • More than one surgical treatment for hepatocellular carcinoma; Received more than 1 prophylactic Transcatheter Arterial Chemoembolization (TACE) treatment after surgery; or received Hepatic Artery Infusion Chemotherapy (HAIC) therapy after surgery.
  • Previous use of antiangiogenic drugs or PD-1, Programmed Cell Death-Ligand 1 (PD-L1) and other related immunotherapy drugs or systemic chemotherapy drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 67 centers
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • Anhui Provincial Hospital — Hefei
  • The First Affiliated Hospital of Anhui Medical University — Hefei
  • Peking Union Medical College Hospital — Beijing
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Peking University People's Hospital — Beijing
  • Beijing Friendship hospital of Capital Medical University — Beijing
  • Beijing YouAn Hospital,Capital Medical University — Beijing
  • … and 59 more centers

Identifiers

NCT: NCT05862337 · ALTN-AK105-III-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗