Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma

Phase 2

Recruiting

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Drug: Tislelizumab combined with S-1

• Registration Number: NCT06664021
• Lead Sponsor: Anhui Provincial Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-27
• Study First Posted: 2024-10-29
• Study Start: 2024-11-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-75 years old, male and female;
• Intrahepatic cholangiocarcinoma was pathologically confirmed after R0 or R1 resection. Patients were also pathologically confirmed to have one of the following high-risk factors (i.e., positive margins, multiple tumor nodes, positive lymph nodes, positive perineural infiltration, intrahepatic cholangiocarcinoma >5 cm in diameter, and combined vascular invasion);
• Enhanced computed tomography (CT) scans of the chest, abdomen, and pelvis were required within 30 days prior to surgery to demonstrate the absence of distant tumor metastases;
• No history of any chemotherapy, radiotherapy, immunotherapy or interventional therapy within 3 months prior to surgical resection;
• Child-Pugh grade A or B, ECOG score 0-1;
• Normal organ function prior to drug administration: ANC ≥1.5×10^9/L, Hemoglobin ≥90g/L, PLT >50*10^9/L, serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); total bilirubin (TBIL) ≤2 times the upper limit of normal (ULN); glutamine transaminase (AST) or glutamine transaminase (ALT) levels ≤3 times the ULN; urinary protein <2+ (if urinary protein) upper limit of normal (ULN); albumin transaminase (AST) or alanine transaminase (ALT) levels ≤3 times upper limit of normal (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: a. International normalized ratio INR ≤ 1.5 x ULN; b. Partial thromboplastin time APTT ≤ 1.5 x ULN; c. Prothrombin time PT ≤ 1.5 ULN;
• In case of hepatitis B virus (HBV) infection: if HBsAg-positive, HBV-DNA testing is required and HBV-DNA must be <2000 IU/mL and willing to receive antiviral therapy throughout the study period; hepatitis C virus (HCV)-RNA-positive patients must have HCV-RNA <1×10^3copy/mL and must receive antiviral therapy according to treatment guidelines.
• No major abnormalities in heart, lung or kidney function;
• No history of gastrointestinal hemorrhage;
• Sign the informed consent form.

Exclusion Criteria

• The tumor is not completely resected, or the pathological diagnosis suggests non-intrahepatic cholangiocarcinoma such as hepatocellular carcinoma, mixed hepatocellular carcinoma, and hepatoportal cholangiocarcinoma;
• Pregnant or breastfeeding women;
• Combined with other malignant tumors;
• Have any active autoimmune disease or a history of autoimmune disease;
• Uncontrolled clinically significant cardiac disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the last 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
• The patient has a congenital or acquired immunodeficiency;
• Uncontrollable infection > grade 2 (NCI-CTC version 5.0);
• Psychopaths;
• Patients have participated in other clinical trials within the past three months;
• Postoperative patients receiving other targeted agents, immunotherapy such as PD-1 antibodies, and FOLFOX systemic chemotherapy;
• Patients who are not suitable to participate in the study as determined by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Tislelizumab combined with S-1	Tislelizumab + S-1

Primary Outcome Measures

Name	Time	Method
1-year RFS rate	12 months	Proportion of patients with no local, regional, or metastatic ICC or death from any cause (whichever occurs first) 12 months after hepatectomy.

Secondary Outcome Measures

Name	Time	Method
RFS	24 months	Time from hepatectomy to the first documented occurrence of local, regional, or metastatic ICC or death from any cause, whichever occurs first.
OS	24 months	Time from hepatectomy to first recorded occurrence of death from any cause
Survival time after recurrence	24 months	The time from the first documented occurrence of localized, regional, or metastatic ICC, whichever occurs first, to death from any cause.
AEs AEs AEs AEs AE	24 months	Adverse Events (AEs)The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0

Trial Locations

Locations (2)

No.2 People's Hospital of Fuyang city; 🇨🇳 Fuyang, Anhui, China

Anhui province hospital; 🇨🇳 Hefei, Anhui, China