NCT05254847已完成2 期
Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With Biliary Tract Cancer: A Single-arm, Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- 1 year DFS rate
研究概览
简要总结
This is a prospective, open-label, single-center clinical study, to evaluate the efficacy and safety of Capecitabine combined with Lenvatinib and Tislelizumab as adjuvant treatment after resection in patients with biliary tract cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 and above
- •Pathological reported showed Biliary tract cancer (include intrahepatic cholangiocarcinoma (IHCC), extrahepatic/hilar cholangiocarcinoma, muscle infiltrated gallbladder carcinoma or distal cholangiocarcinoma)，patients received R0 resection(including liver resection, pancreatectomy, or both).
- •ECOG PS 0-1
- •Patients can tolerate the combination therapy and survive longer than 6 months.
- •Organ function(Exclude use blood components and cell growth factors for 14 days): Neutrophils (ANC) ≥1,500/mm3, Platelet count (PLT)≥100,000/mm3, Hemoglobin (Hb) ≥9g/dL; Serum creatinine(SCR) ≤1.5*upper limit of normal(ULN),or creatinine clearance rate≥50 ml/min(Cockcroft-Gault Formula),Total bilirubin(TBIL)≤ 2*ULN,Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3*ULN, urine protein≤2+(if urine protein≥2+, 24-hour urinary protein quantity must ≤1g), Adequate surgical biliary drainage and no infection signal.
- •The coagulation function was normal (without active bleeding and thrombotic disease): International normalized ratio(INR)≤1.5*ULN, activated partial thromboplastin time(APTT)≤1.5×ULN, prothrombin time(PT)≤1.5*ULN.
- •Women without surgical sterilization or childbearing age who are required to use a medically approved contraceptive method (such as an intrauterine device, birth control pill or condom) during the study period and for 3 months after the study period; Women are of reproductive age and not undergoing surgical sterilization whose the serum or urine HCG test must be negative within 7 days prior to study enrollment and must be non lactation period. Male patients without surgical sterilization or reproductive age are required to consent with their spouse to use a medically approved contraceptive method during the study treatment period and for 3 months after the study treatment period.
- •The patients are voluntarily enrolled in the study, with good compliance and coordinate the follow-up for safety and survival
排除标准
- •Patients with pancreatic/ampullary carcinoma
- •Patients with mucous gallbladder carcinoma
- •Patients who had received radiotherapy or chemotherapy previously
- •Incomplete surgery recovery or biliary obstruction exist
- •Patients with radiographs confirmed distant metastases
- •Patients with prior or concurrent malignancy(excluded Cured basal cell carcinoma of the skin and Carcinoma in situ elsewhere)
- •Patients are allergy to macromolecular protein preparation(including anti-PD-1 antibody, uracil, cytosine pharmaceutical ingredients)
- •There are significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
- •Patients had any active autoimmune disease or had experience of autoimmune disease.
- •Patients are receiving immunosuppressant and continue using within 2 weeks before enrollment
- •Patients with ascites or pleural effusion requiring therapeutic puncture or drainage
- •Patients with disease of the heart that are not well controlled
- •Abnormal coagulation(have tendency to bleed or receiving thrombolytic or anticoagulant therapy)
- •Patients had active infection or unexplained fever during screening and before first dose
- •Patients had abdominal fistula, gastrointestinal perforation, or abdominal abscess less than 4 weeks before first dose.
- •Patients past or present with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc
- •Patients have congenital or acquired immune deficiency; Hepatitis B patients: HBV DNA≥10^3/ml, Hepatitis C patients: HCV RNA≥10^3/ml, Chronic hepatitis B virus carriers: HBV DNA<2000 IU/ml（<10^4 copies/ml), patients must receive antiviral therapy during the trial
- •Patients are participating in other relevant clinical studies or it has been less than 1 month since the end of the previous clinical study; Patients maybe receive other systemic antitumor therapy during the study period;
- •Patients received live vaccination less than 4 weeks before administration or possibly receive during the study period.
- •Patients had history of psychotropic substance abuse, alcohol abuse, or drug abuse.
- •Patients cannot or does not agree to pay the cost of examination and treatment expense
- •The researchers concluded the patients should be excluded from this study
研究组 & 干预措施
combined treatment group
Experimental
Capecitabine combined with lenvatinib and tislelizumab: Lenvatinib,8mg po. qd.Tislelizumab,200mg iv. q3w. Capecitabine 1250mg/m^2 bid.d1-d14 q3w
干预措施: Capecitabine combined with lenvatinib and tislelizumab (Drug)
结局指标
主要结局
1 year DFS rate
时间窗: 12 month
one year disease free survival rate
次要结局
- 2 years DFS rate(24 month)
- 1 year OS rate(12 month)
- 3 years OS rate(36 month)
- AE(30 days from the beginning of treatment to the last treatment)
研究者
Lu Wang, MD, PhD
Head of liver surgery department
Fudan University
研究点 (1)
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