Recruiting

TACE Combined With Anti-PD-1 Antibody in Patients With Advanced Hepatocellular Carcinoma

# NCT04297280 Trial phase: 2 Study type: immunotherapy, local

Study Start Date

April, 2020

Scientific Title

A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined With Anti-PD-1 Antibody (IBI308) in Patients With Advanced Hepatocellular Carcinoma

Summary

The objective of this study is to evaluate the efficacy and safety of transcatheter arterial chemoembolization combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma as first line therapy.

- Written informed consent obtained. - Age ≥ 18 years at time of study entry. - Multinodular or large, solitary hepatocellular carcinoma, not eligible for resection or local ablation, Tumor burden below 50% of liver volume. - Histologically confirmed diagnosis of hepatocellular carcinoma. - At least one measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI. - Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale). - Subjects with chronic HBV infection must have HBV DNA viral load < 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. - Life expectancy of at least 12 weeks. - Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula ) - Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. - Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

Study Design

Primary purpose: Treatment , Allocation: N/A , Intervention model: Single Group Assignment , Masking: None (Open Label)

Conditions

Hepatocellular Carcinoma

Locations

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