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A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

NCT05489289 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2025-03-12

No results posted yet for this study

Summary

The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.

Conditions

Interventions

BIOLOGICAL

AK104

Subjects will receive AK104 until disease progression or for a maximum of 16 cycles

BIOLOGICAL

placebo

Subjects will receive placebo until disease progression or for a maximum of 16 cycles

Sponsors & Collaborators

Principal Investigators

  • Jia Fan, Ph.D. · Fudan University

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
2023-01-05
Primary Completion
2026-01-28
Completion
2027-01-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05489289 on ClinicalTrials.gov