OncoMatch/Clinical Trials/NCT04823403
Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma
Is NCT04823403 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Nivolumab and Ipilimumab for hepatocellular carcinoma.
Treatment: Nivolumab · Ipilimumab — To determine the Maximum Tolerated Dose (MTD), and the recommended Phase 2 dose of HIA Ipilimumab in combination with IV Nivolumab by monitoring the Dose Limiting Toxicity (DLT) within 1 month after IA Ipilimumab administration in dose-escalation phase.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage ADVANCED HCC, BCLC C (BCLC)
Patient should be considered as non resectable by Multidisciplinary Team and liver surgeon, and non-eligible for liver transplantation (advanced HCC, BCLC C). Patients should have measurable disease as defined by mRECIST criteria for response assessment.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard first line therapy
Patient who progresses on, or is intolerant to, or has refused standard first line therapy
Cannot have received: any investigational drug
Any other investigational drug
Cannot have received: anticancer therapy (chemotherapy, biologics, therapeutic vaccines, radiotherapy, or hormonal treatment)
Any anticancer therapy (chemotherapy, biologics, therapeutic vaccines, radiotherapy, or hormonal treatment)
Cannot have received: vaccines containing live virus
Vaccines containing live virus
Cannot have received: allergen hyposensitization therapy
Allergen hyposensitization therapy
Cannot have received: growth factors (granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin)
Growth factors, e.g., granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin
Cannot have received: bisphosphonates or anti-RANKL therapy
Bisphosphonates or anti-RANKL therapy
Cannot have received: major surgery
Major surgery
Lab requirements
Blood counts
White blood cells (WBCs) ≥ 2000/mL; Neutrophils ≥ 1000/mL; Platelets ≥ 75 × 10^3/mL; Hemoglobin ≥ 8.0 g/dL
Kidney function
Creatinine < 1.5 × ULN or creatinine clearance ≥ 40mL/min (Cockcroft-Gault formula)
Liver function
ALT and AST ≤ 3 × ULN or < 5 x ULN in case of liver metastasis; Total bilirubin ≤ 1.5 × ULN; Child-Pugh A, Without history of encephalopathy or clinically significant ascites
Adequate organ function as defined by the following: WBCs ≥ 2000/mL; Neutrophils ≥ 1000/mL; Platelets ≥ 75 × 10^3/mL; Hemoglobin ≥ 8.0 g/dL; Creatinine < 1.5 × ULN or creatinine clearance ≥ 40mL/min (Cockcroft-Gault formula); ALT and AST ≤ 3 × ULN or < 5 x ULN in case of liver metastasis; Lipase and amylase ≤ 1.5 × ULN; Total bilirubin ≤ 1.5 × ULN; Normal thyroid function, or stable on hormone supplementation per investigator assessment; Child-Pugh A, Without history of encephalopathy or clinically significant ascites
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04823403 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior any investigational drug, anticancer therapy (chemotherapy, biologics, therapeutic vaccines, radiotherapy, or hormonal treatment), vaccines containing live virus disqualifies patients from enrollment.
What disease stage is eligible?
Stage ADVANCED HCC or BCLC C is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages