Combining AK104 and Lenvatinib with TACE for treating liver cancer
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
This study is testing if combining two treatments, AK104 and lenvatinib, with a procedure called TACE can help people with liver cancer who can't have surgery feel better compared to just having TACE alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 469 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Drugs / interventions | cadonilimab, lenvatinib |
| Locations | 4 sites (Zhengzhou, Henan and 3 other locations) |
| Trial ID | NCT06371157 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with non-metastatic hepatocellular carcinoma who are not eligible for curative treatments but can undergo TACE.
Not a fit: Patients with a history of liver transplantation, uncontrolled hypertension, or co-infection with HBV and HCV may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer who currently have limited treatment choices.
How similar studies have performed: Other studies have explored similar combination therapies in liver cancer, showing promising results, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou, Henan and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.