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

March 11, 2025 updated by: Akeso

A Randomized, Double-blind, Phase III Clinical Study on the Efficacy and Safety of AK104 Versus Placebo as Adjuvant Therapy for Hepatocellular Carcinoma With High Risk of Recurrence After Curative Resection

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

570

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathological diagnosis of HCC without any metastasis;
  2. Receiving radical resection as the only anti-tumor treatment;
  3. No evidence of residual cancer found during or after the operation;
  4. Presence of any high risk factor of postoperative recurrence;
  5. Child-Pugh grade: A;
  6. ECOG score: 0;
  7. Controlled underlying causes of HCC.

Exclusion Criteria:

  1. Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc;
  2. Any anti-tumor treatment other than radical surgery before randomization;
  3. Precarious liver function indicated by severe complications;
  4. Recent procedures or medications leading to high risk of bleeding;
  5. Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, etc;
  6. Failure of performing enhanced CT or MRI scans of the liver;
  7. Recent severe infections or systemic antibiotics use;
  8. Active autoimmune diseases;
  9. History of other incurable malignant tumors;
  10. History of transplantation;
  11. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AK104
AK104 IV every three weeks
Biological: AK104
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
Placebo Comparator: placebo
Placebo IV every three weeks
Biological: placebo
Subjects will receive placebo until disease progression or for a maximum of 16 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival (RFS) by BICR
Time Frame: Up to 48 months
The time comfirmed by BICR from randomization to recurrence or death.
Up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-months recurrence free survival (RFS-12)
Time Frame: 12 months
The proportion of patients without recurrence or death at 12 month.
12 months
24-months recurrence free survival (RFS-24)
Time Frame: 24 months
The proportion of patients without recurrence or death at 24 month.
24 months
Time to recurrence (TTR)
Time Frame: Up to 48 months
The time from randomization to recurrence.
Up to 48 months
Overall survival (OS)
Time Frame: Up to 48 months
The time from randomization to death for any reason.
Up to 48 months
Types and proportions of adverse events (AEs)
Time Frame: Up to 48 months
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Investigators

  • Principal Investigator: Jia Fan, Ph.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Estimated)

January 28, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK104-306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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