Clinical trial · Interventional
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
NCT06371157CI-TRIAL-00087063recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Placebo for AK104 | Other | — | UNRESOLVED |
| Placebo for Lenvatinib | Other | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE)
- interventionNames
- Drug: AK104
- Drug: Lenvatinib
- Procedure: TACE
- type
- PLACEBO_COMPARATOR
- label
- Arm B
- description
- Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE
- interventionNames
- Procedure: TACE
- Other: Placebo for AK104
- Other: Placebo for Lenvatinib
- type
- OTHER
- label
- Arm C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.