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 (Jun 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
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06664021 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages