search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AK104
placebo
Sponsored by
Akeso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AK104

placebo

Arm Description

AK104 IV every three weeks

Placebo IV every three weeks

Outcomes

Primary Outcome Measures

Recurrence free survival (RFS) by BICR
The time comfirmed by BICR from randomization to recurrence or death.

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2022
Last Updated
August 4, 2022
Sponsor
Akeso
search

1. Study Identification

Unique Protocol Identification Number
NCT05489289
Brief Title
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 24, 2022 (Anticipated)
Primary Completion Date
January 28, 2025 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AK104
Arm Type
Active Comparator
Arm Description
AK104 IV every three weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo IV every three weeks
Intervention Type
Biological
Intervention Name(s)
AK104
Intervention Description
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Subjects will receive placebo until disease progression or for a maximum of 16 cycles
Primary Outcome Measure Information:
Title
Recurrence free survival (RFS) by BICR
Description
The time comfirmed by BICR from randomization to recurrence or death.
Time Frame
Up to 48 months
Secondary Outcome Measure Information:
Title
12-months recurrence free survival (RFS-12)
Description
The proportion of patients without recurrence or death at 12 month.
Time Frame
12 months
Title
24-months recurrence free survival (RFS-24)
Description
The proportion of patients without recurrence or death at 24 month.
Time Frame
24 months
Title
Time to recurrence (TTR)
Description
The time from randomization to recurrence.
Time Frame
Up to 48 months
Title
Overall survival (OS)
Description
The time from randomization to death for any reason.
Time Frame
Up to 48 months
Title
Types and proportions of adverse events (AEs)
Time Frame
Up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Liu, M.D.
Phone
(0760)89873999
Email
clinicaltrials@akesobio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan, Ph.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Fan, Ph.D.
Phone
021-31587871
Email
fan.jia@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs