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Trial Title:
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
NCT ID:
NCT06371157
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
Description:
intravenous
Arm group label:
Arm A
Arm group label:
Arm C
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
oral
Arm group label:
Arm A
Intervention type:
Procedure
Intervention name:
TACE
Description:
TACE (chemo and embolic agent injection into the hepatic artery)
Arm group label:
Arm A
Arm group label:
Arm B
Arm group label:
Arm C
Intervention type:
Other
Intervention name:
Placebo for AK104
Description:
intravenous
Arm group label:
Arm B
Intervention type:
Other
Intervention name:
Placebo for Lenvatinib
Description:
oral
Arm group label:
Arm B
Arm group label:
Arm C
Summary:
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial
chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic
hepatocellular carcinoma
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450004
Country:
China
Contact:
Last name:
Hailiang Li
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410006
Country:
China
Contact:
Last name:
Shanzhi Gu
Facility:
Name:
Zhongda Hospital Southeast University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Contact:
Last name:
Gaojun Teng
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030009
Country:
China
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650100
Country:
China
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Contact:
Last name:
Guoliang Shao
Start date:
July 2, 2024
Completion date:
May 23, 2026
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06371157
