OncoMatch/Clinical Trials/NCT06664021
Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma
Is NCT06664021 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab combined with S-1 for intrahepatic cholangiocarcinoma.
Treatment: Tislelizumab combined with S-1 — Evaluating the efficacy and safety of treatment with Tislelizumab in combination with S-1 in patients with high-risk recurrent intrahepatic cholangiocarcinoma after radical surgery
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
No history of any chemotherapy, radiotherapy, immunotherapy or interventional therapy within 3 months prior to surgical resection
Cannot have received: radiotherapy
No history of any chemotherapy, radiotherapy, immunotherapy or interventional therapy within 3 months prior to surgical resection
Cannot have received: immunotherapy
No history of any chemotherapy, radiotherapy, immunotherapy or interventional therapy within 3 months prior to surgical resection
Cannot have received: interventional therapy
No history of any chemotherapy, radiotherapy, immunotherapy or interventional therapy within 3 months prior to surgical resection
Cannot have received: targeted therapy
Postoperative patients receiving other targeted agents, immunotherapy such as PD-1 antibodies, and FOLFOX systemic chemotherapy
Cannot have received: immunotherapy (PD-1 antibodies)
Postoperative patients receiving other targeted agents, immunotherapy such as PD-1 antibodies, and FOLFOX systemic chemotherapy
Cannot have received: systemic chemotherapy (FOLFOX)
Postoperative patients receiving other targeted agents, immunotherapy such as PD-1 antibodies, and FOLFOX systemic chemotherapy
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, Hemoglobin ≥90g/L, PLT >50×10^9/L
Kidney function
serum creatinine ≤ 1.5x ULN or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); urine protein <2+ (if urine protein ≥2+, 24-hour urine protein quantification must show ≤1g of protein)
Liver function
total bilirubin (TBIL) ≤2x ULN; AST or ALT ≤3x ULN; albumin transaminase (AST) or alanine transaminase (ALT) ≤3x ULN; adequate surgical biliary drainage with no signs of infection
Cardiac function
No major abnormalities in heart function; uncontrolled clinically significant cardiac disease excluded
Normal organ function prior to drug administration: ANC ≥1.5×10^9/L, Hemoglobin ≥90g/L, PLT >50×10^9/L, serum creatinine (SCr) ≤ 1.5x ULN or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤2x ULN; AST or ALT ≤3x ULN; albumin transaminase (AST) or alanine transaminase (ALT) ≤3x ULN; urine protein <2+ (if urine protein ≥2+, 24-hour urine protein quantification must show ≤1g of protein); and adequate surgical biliary drainage with no signs of infection. Normal coagulation function: INR ≤ 1.5x ULN; APTT ≤ 1.5x ULN; PT ≤ 1.5x ULN. No major abnormalities in heart, lung or kidney function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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