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

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: placebo; Biological: AK104

• Registration Number: NCT05489289
• Lead Sponsor: Akeso

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-05
• Study Start: 2023-01-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-01-28
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 570

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Placebo IV every three weeks
AK104	AK104	AK104 IV every three weeks

Primary Outcome Measures

Name	Time	Method
Recurrence free survival (RFS) by BICR	Up to 48 months	The time comfirmed by BICR from randomization to recurrence or death.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China