Clinical trial · Interventional
A Phase II Study of AK104 Plus Lenvatinib and TACE in HCC
An Open Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AK104 Plus Lenvatinib and TACE in the Treatment of Unresectable, Non-metastatic Hepatocellular Carcinoma
NCT05319431CI-TRIAL-00087059active not recruitingPhase 2ClinicalTrials.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)
To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, 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 |
|---|---|---|---|
| Unresectable, Non-metastatic Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Biological | — | UNRESOLVED |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK104+Lenvatinib+TACE
- description
- Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study.
- interventionNames
- Biological: AK104
- Drug: Lenvatinib
- Procedure: TACE
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Up to 2 years
- description
- Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first.
Secondary outcomes (4)
- measure
- Objective response rate (ORR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent form voluntarily. * Histologically or cytologically documented hepatocellular carcinoma. * CNLC IIa IIb or IIIa * The main portal vein was not completely obstructed, * Child-Pugh A or B * At least one measurable lesion according to RECIST criteria * ECOG PS 0-1 * Adequate organ function * Estimated life expectancy of ≥3 months * For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent Exclusion Criteria: * Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc * For HCC lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions * The main portal vein and the left and right primary branches were clogged with cancer thrombus * History of hepatic encephalopathy or liver transplantation * Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy. * Occurred arteriovenous thromboembolic events within 6 months before the first administration. * Inadequately controlled hypertension. * Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome. * Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease. * Severe infections. * Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy, * Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs. * Unable to receive an enhanced CT or MRI scan of the liver.
References
Publications (0)
Data not yet available
No reference posted for this study.