NCT06371157RecruitingPhase 3
A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 469 (estimated)
- First submitted
- 15 Apr 2024
- Start date
- 2 Aug 2024
- Primary completion date
- 25 Oct 2025
- Lead sponsor
- Akeso
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06371157
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 469
- From 2 Aug 2024 to the primary completion date, 25 Oct 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Deep venous thrombosis within 3 months before first treatment
Other illness
- History of liver transplantation
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Bleeding events within the last 6 months
- Co-infection with HBV and HCV
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.