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

NCT05862337 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2023-05-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2024-08-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05862337 on ClinicalTrials.gov