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

Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma：A Prospective, Multicenter, Phase II Clinical Study

This study is testing if a combination of the immunotherapy drug Tislelizumab and the chemotherapy drug S-1 can help people with high-risk recurrent intrahepatic cholangiocarcinoma feel better after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy, Tislelizumab
• Locations: 2 sites (Fuyang, Anhui and 1 other locations)
• Trial ID: NCT06664021 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed high-risk recurrent intrahepatic cholangiocarcinoma after surgery.

Not a fit: Patients with distant metastases or those who have received prior chemotherapy, radiotherapy, or immunotherapy within three months before surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with high-risk recurrent intrahepatic cholangiocarcinoma.

How similar studies have performed: While this specific combination has not been widely tested, similar immunotherapy and chemotherapy combinations have shown promise in treating various cancers.

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.

Where this trial is running

Fuyang, Anhui and 1 other locations

• 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

Conditions Intrahepatic Cholangiocarcinoma