NCT04823403 Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma
| NCT ID | NCT04823403 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2020-11-13 |
| Primary Completion | 2022-11-04 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adult Men and women ≥ 18 years old 2. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. 3. Patient should be able to comply with treatment, PK, and pharmacodynamic sample collection and willing to comply with study visits and procedures as per protocol. 4. Patients must have pathological confirmation of HCC. 5. Patient should be considered as non resectable by Multidisciplinary Team and liver surgeon, and non-eligible for liver transplantation (advanced HCC, BCLC C). 6. Patient who progresses on, or is intolerant to, or has refused standard first line therapy and eligible for receiving IV infusion of Nivolumab and HIA administration of Ipilimumab 7. Patient with active intrahepatic HCC. Part of the disease should not have undergone local treatments (including chemoembolization, or percutaneous targeted therapies). 8. Patients with or without active viral infection (i.e., HCV, HBV) are
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