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

RecruitingPhase 3Ages 18 Years - 75 YearsAllAkeso
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • AK104
  • Lenvatinib
  • TACE
  • Placebo for AK104
  • Placebo for Lenvatinib
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Where

4 sites
Henan Cancer Hospital
Zhengzhou, China
Hunan Cancer Hospital
Changsha, China
Zhongda Hospital Southeast University
Nanjing, China
Zhejiang Cancer Hospital
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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