Treatment for high-risk recurrent intrahepatic cholangiocarcinoma using Tislelizumab and S-1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of Tislelizumab, an immunotherapy drug, in combination with S-1, a chemotherapy agent, for patients who have undergone surgery for high-risk recurrent intrahepatic cholangiocarcinoma. The study focuses on patients who have specific high-risk factors following radical surgery, such as positive margins or multiple tumor nodes. Participants will be monitored for treatment outcomes and safety over the course of the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• No.2 People's Hospital of Fuyang city
  Fuyang, Anhui, China Recruiting
• Anhui province hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Lian-xin Liu — Anhui Provincial Hospital
• Study coordinator: Ji-Zhou Wang
• Email: wangjoe@ustc.edu.cn
• Phone: +86 13836135864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.