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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05489289
• Other study ID #: AK104-306
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 24, 2022
• Est. completion date: November 1, 2026

Study information

• Verified date: August 2022
• Source: Akeso
• Contact: Ting Liu, M.D.
• Phone: (0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 405
• Est. completion date: November 1, 2026
• Est. primary completion date: January 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

Biological:
• AK104
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
• placebo
Subjects will receive placebo until disease progression or for a maximum of 16 cycles

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival (RFS) by BICR	The time comfirmed by BICR from randomization to recurrence or death.	Up to 48 months
Secondary	12-months recurrence free survival (RFS-12)	The proportion of patients without recurrence or death at 12 month.	12 months
Secondary	24-months recurrence free survival (RFS-24)	The proportion of patients without recurrence or death at 24 month.	24 months
Secondary	Time to recurrence (TTR)	The time from randomization to recurrence.	Up to 48 months
Secondary	Overall survival (OS)	The time from randomization to death for any reason.	Up to 48 months
Secondary	Types and proportions of adverse events (AEs)		Up to 48 months