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

NCT ID: NCT06664021

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-16
• Study Completion Date: 2026-12-30

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

Conditions

Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Tislelizumab + S-1

Group Type: EXPERIMENTAL

Tislelizumab combined with S-1

Intervention Type: DRUG

Tislelizumab：200mg q3w iv , lasts for one year. S-1：40mg, 50mg, or 60mg orally twice daily for 4 weeks, depending on body surface area, followed by 2 weeks of rest，lasts four cycles.

No treatment group

No postoperative adjuvant therapy is performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tislelizumab combined with S-1

Tislelizumab：200mg q3w iv , lasts for one year. S-1：40mg, 50mg, or 60mg orally twice daily for 4 weeks, depending on body surface area, followed by 2 weeks of rest，lasts four cycles.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lian-xin Liu

Role: PRINCIPAL_INVESTIGATOR

Anhui Provincial Hospital

Locations

No.2 People's Hospital of Fuyang city

Fuyang, Anhui, China

Site Status: RECRUITING

Anhui province hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ji-Zhou Wang

Role: CONTACT

wangjoe@ustc.edu.cn

+86 13836135864

Facility Contacts

DaYong Luo

Role: primary

fyldy7172@sina.com

13805587172

Ji-Zhou Wang, M.D.

Role: primary

wangjoe@ustc.edu.cn

+86 13836135864

Other Identifiers

2024KY467

Identifier Type: -

Identifier Source: org_study_id