OncoMatch/Clinical Trials/NCT05010681
Lenvatinib Plus Sintilimab in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Liver Cancer
Is NCT05010681 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sintilimab and Lenvatinib for intrahepatic cholangiocarcinoma.
Treatment: Sintilimab · Lenvatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy
disease progression with an anti-PD-1 or anti-PD-L1 based regimen
Must have received: anti-PD-L1 therapy
disease progression with an anti-PD-1 or anti-PD-L1 based regimen
Cannot have received: VEGFR inhibitor (lenvatinib)
Prior treatment with Lenvatinib or other targeted therapy
Cannot have received: targeted therapy
Prior treatment with Lenvatinib or other targeted therapy
Cannot have received: radiofrequency ablation
RFA and resection administered less then 4 weeks prior to study treatment start
Cannot have received: surgical resection
RFA and resection administered less then 4 weeks prior to study treatment start
Cannot have received: radiation therapy
Radiotherapy administered less then 4 weeks prior to study treatment start
Cannot have received: major surgery
Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery
Lab requirements
Blood counts
absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L
Kidney function
Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
Liver function
Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); Albumin ≥ 31 g/dL; International normalized ratio (INR) ≤1.25
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 )
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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