A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK104, Lenvatinib, TACE, Placebo for AK104.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
Interventions
- Drug AK104
intravenous - Drug Lenvatinib
oral - Procedure TACE
TACE (chemo and embolic agent injection into the hepatic artery) - Other Placebo for AK104
intravenous - Other Placebo for Lenvatinib
oral
Primary outcome measures
- Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Time frame: Up to approximately 2 years]
Secondary outcome measures (6)
- Overall Survival (OS) [Time frame: Up to approximately 2 years]
- PFS per RECIST 1.1 [Time frame: Up to approximately 2 years]
- Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) [Time frame: Up to approximately 2 years]
- Duration of Response (DOR) per RECIST 1.1 and mRECIST [Time frame: Up to approximately 2 years]
- Disease Control Rate (DCR) per RECIST 1.1 and mRECIST [Time frame: Up to approximately 2 years]
- Time to Response (TTR) per RECIST 1.1 and mRECIST [Time frame: Up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Henan Cancer Hospital — Zhengzhou
- Hunan Cancer Hospital — Changsha
- Zhongda Hospital Southeast University — Nanjing
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT06371157 · AK104-308