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

NCT05489289 | Recruiting Phase 3

• 1 other identifier: AK104-306
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival (RFS) by BICR

  The time comfirmed by BICR from randomization to recurrence or death.

  Up to 48 months

Secondary Outcomes (5)

• 12-months recurrence free survival (RFS-12)

  12 months

• 24-months recurrence free survival (RFS-24)

  24 months

• Time to recurrence (TTR)

  Up to 48 months

• Overall survival (OS)

  Up to 48 months

• Types and proportions of adverse events (AEs)

  Up to 48 months

Study Arms (2)

AK104

ACTIVE COMPARATOR

AK104 IV every three weeks

Biological: AK104

placebo

PLACEBO COMPARATOR

Placebo IV every three weeks

Biological: placebo

Interventions

AK104 BIOLOGICAL

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

AK104

placebo BIOLOGICAL

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

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jia Fan, Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu, M.D.

CONTACT

(0760)89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: January 5, 2023
• Primary Completion: January 28, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)