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

Официальное название

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

Обзор

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

Вмешательства

• Препарат 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.

Первичные конечные точки

• 1-year RFS rate [Срок оценки: 12 months]

Вторичные конечные точки (4)

• RFS [Срок оценки: 24 months]
• OS [Срок оценки: 24 months]
• Survival time after recurrence [Срок оценки: 24 months]
• AEs AEs AEs AEs AE [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• No.2 People's Hospital of Fuyang city — Fuyang
• Anhui province hospital — Хэфэй

Идентификаторы

NCT: NCT06664021 · 2024KY467

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗