A Phase II Study of Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer
The objective of this study is to evaluate the efficacy and safety of Lenvatinib plus Sintilimab in patients with advanced liver cancer progressed after treatment with immune checkpoint inhibitors.
• Written informed consent obtained.
• Age ≥ 18 years at time of study entry.
• Participants must have unresectable or metastatic histologically or cytologically confirmed hepatocellular carcinoma or intrahepatic cholangiocarcinoma
• Participants must have disease progression with an anti-PD-1 or anti-PD-L1 based regimen.
• At least one measurable site of disease as defined by RECIST 1.1 criteria with spiral CT scan or MRI.
• Performance status (PS) ≤ 2 (ECOG scale).
• Life expectancy of at least 12 weeks.
• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 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.