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

Launched by ANHUI PROVINCIAL HOSPITAL · Oct 27, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with high-risk intrahepatic cholangiocarcinoma, a type of cancer that starts in the bile ducts inside the liver, after they have undergone surgery. The study is testing the combination of two medications: Tislelizumab, which is an immunotherapy that helps the body fight cancer, and S-1, a chemotherapy drug. Researchers want to see how effective and safe this combination is in preventing the cancer from coming back after surgery.

To participate in this trial, candidates must be between 18 and 75 years old and have had surgery to remove their cancer, but still show high-risk factors like positive margins or multiple tumor nodes. Patients should have normal organ function and no recent treatments for their cancer. Throughout the study, participants will receive regular health check-ups to monitor their response to the treatment and any side effects. It’s important to note that this trial is currently recruiting participants, so those who meet the eligibility criteria and are interested in this treatment option should consider discussing it with their healthcare provider.

Gender

ALL

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.