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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06371157
Other study ID # AK104-308
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 2, 2024
Est. completion date May 23, 2026

Study information

Verified date April 2024
Source Akeso
Contact Ting Liu
Phone +86 (0760) 8987 3999
Email clinicaltrials@akesobio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 469
Est. completion date May 23, 2026
Est. primary completion date October 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. 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) 2. No evidence of metastasis 3. Not amenable to curative surgery or transplantation or curative ablation but amenable to TACE 4. Child Pugh score class A 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment 6. Measurable disease by RECIST 1.1 7. Adequate organ function Exclusion Criteria: 1. History of liver transplantation 2. History of hepatic encephalopathy 3. Uncontrolled arterial hypertension 4. Deep venous thrombosis within 3 months before first treatment 5. Bleeding events within the last 6 months 6. Co-infection with HBV and HCV

Study Design


Intervention

Drug:
AK104
intravenous
Lenvatinib
oral
Procedure:
TACE
TACE (chemo and embolic agent injection into the hepatic artery)
Other:
Placebo for AK104
intravenous
Placebo for Lenvatinib
oral

Locations

Country Name City State
China Hunan Cancer Hospital Changsha Hunan
China Sichuan Cancer Hospital Chengdu Sichuan
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Yunnan Cancer Hospital Kunming Yunnan
China Zhongda Hospital Southeast University Nanjing Jiangsu
China Shanxi Cancer Hospital Taiyuan Shanxi
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Survival (OS) OS is defined as the time from randomization to death due to any cause. Up to approximately 2 years
Secondary PFS per RECIST 1.1 Assessed by investigators Up to approximately 2 years
Secondary Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Assessed by BICR and investigators Up to approximately 2 years
Secondary Duration of Response (DOR) per RECIST 1.1 and mRECIST Assessed by BICR and investigators Up to approximately 2 years
Secondary Disease Control Rate (DCR) per RECIST 1.1 and mRECIST Assessed by BICR and investigators Up to approximately 2 years
Secondary Time to Response (TTR) per RECIST 1.1 and mRECIST Assessed by BICR and investigators Up to approximately 2 years
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