NCT06371157

Brief Summary

A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
469

participants targeted

Target at P75+ for phase_3 hepatocellular-carcinoma

Timeline
1mo left

Started Aug 2024

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Aug 2024May 2026

First Submitted

Initial submission to the registry

April 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 2, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2026

Expected
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

April 15, 2024

Last Update Submit

March 11, 2025

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).

    Up to approximately 2 years

Secondary Outcomes (6)

  • Overall Survival (OS)

    Up to approximately 2 years

  • PFS per RECIST 1.1

    Up to approximately 2 years

  • Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    Up to approximately 2 years

  • Duration of Response (DOR) per RECIST 1.1 and mRECIST

    Up to approximately 2 years

  • Disease Control Rate (DCR) per RECIST 1.1 and mRECIST

    Up to approximately 2 years

  • +1 more secondary outcomes

Study Arms (3)

Arm A

EXPERIMENTAL

AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)

Drug: AK104Drug: LenvatinibProcedure: TACE

Arm B

PLACEBO COMPARATOR

Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE

Procedure: TACEOther: Placebo for AK104Other: Placebo for Lenvatinib

Arm C

OTHER

AK104 + Placebo for Lenvatinib in Combination With TACE

Drug: AK104Procedure: TACEOther: Placebo for Lenvatinib

Interventions

AK104DRUG

intravenous

Arm AArm C
LenvatinibDRUG

oral

Arm A
TACEPROCEDURE

TACE (chemo and embolic agent injection into the hepatic artery)

Arm AArm BArm C
Placebo for AK104OTHER

intravenous

Arm B
Placebo for LenvatinibOTHER

oral

Arm BArm C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has a diagnosis of HCC confirmed by histology/cytology，or meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD)
  • No evidence of metastasis
  • Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE
  • Child Pugh score class A
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
  • Measurable disease by RECIST 1.1
  • Adequate organ function

You may not qualify if:

  • History of liver transplantation
  • History of hepatic encephalopathy
  • Uncontrolled arterial hypertension
  • Deep venous thrombosis within 3 months before first treatment
  • Bleeding events within the last 6 months
  • Co-infection with HBV and HCV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Henan Cancer Hospital

Zhengzhou, Henan, 450004, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Guoliang Shao, MD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

  • Gaojun Teng, MD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu

CONTACT

+86 (0760) 8987 3999clinicaltrials@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

April 15, 2024

First Posted

April 17, 2024

Study Start

August 2, 2024

Primary Completion

October 25, 2025

Study Completion (Estimated)

May 23, 2026

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

CN(4)