Combining AK104 and Lenvatinib with TACE for treating liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of combining cadonilimab (AK104) and lenvatinib with transarterial chemoembolization (TACE) compared to TACE alone in patients with incurable, non-metastatic hepatocellular carcinoma (HCC). Participants must have a confirmed diagnosis of HCC and be unsuitable for curative surgery or transplantation. The study aims to assess the potential benefits of this combination therapy in improving patient outcomes. It is a Phase 3 interventional trial, indicating a focus on determining the efficacy and safety of the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• Zhongda Hospital Southeast University
  Nanjing, Jiangsu, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Guoliang Shao, MD — Zhejiang Cancer Hospital
• Study coordinator: Ting Liu
• Email: clinicaltrials@akesobio.com
• Phone: +86 (0760) 8987 3999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

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• Durvalumab + Tremelimumab with or without Lenvatinib for unresectable liver cancer

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• Treatment for ruptured liver cancer using TACE, Lenvatinib, and PD-1 inhibitors

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• Combining TIPS with Lenvatinib and PD-1 inhibitors for advanced liver cancer with portal vein tumor thrombus

  This study is testing if combining a special procedure with two cancer treatments can help people with advanced liver cancer and a serious blood clot in the portal vein feel better and have better results.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.