A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase III, Randomized, Double-blinded, Multicenter Study of Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06371157
• Other study ID #: AK104-308
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

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