Clinical trial · Interventional
A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma
An Open-Label Multi-Center Phase II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 Alone or in Combination With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma
NCT04728321CI-TRIAL-00076449completedPhase 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)
An open-label multi-center phase II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 alone or in combination with lenvatinib in patients with advanced 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Biological | — | UNRESOLVED |
| AK104 lenvatinib | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AK104
- description
- AK104 15mg/kg IV every 3weeks (Q3W)
- interventionNames
- Biological: AK104
- type
- EXPERIMENTAL
- label
- AK104 and Lenvatinib
- description
- AK104 15 mg/kg IV every 3 weeks (Q3W) Lenvatinib 12mg weight≥60kg or 8mg weight\<60kg,PO QD
- interventionNames
- Biological: AK104 lenvatinib
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 2 years
- description
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. * BCLC stage C, and non-resectable BCLC stage B . * At least one measurable lesion according to RECIST criteria. * ECOG of 0 or 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. * History of hepatic encephalopathy or liver transplantation. * Clinical significance of hydrothorax, ascites or pericardial effusion. * Central nervous system metastases and/or carcinomatous meningitis. * 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. * Tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus. * Inadequately controlled arterial 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.