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OncoMatch/Clinical Trials/NCT04954781

TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

Is NCT04954781 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and TACE for intrahepatic cholangiocarcinoma.

Phase 2RecruitingFudan UniversityNCT04954781Data as of May 2026

Treatment: Tislelizumab · TACEThe objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line
Min 1 prior line

Must have received: systemic therapy — advanced cholangiocarcinoma

Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, ipilimumab)

Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

Lab requirements

Blood counts

absolute neutrophil count ≥ 1,500/L, platelets ≥75 x10^3/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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