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

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Biological: AK104
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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