NCT06717464进行中（未招募）2 期
Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer, Phase II, Single-center, Randomized Controlled Trial
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年11月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 1-year recurrence-free survival rate
研究概览
简要总结
This is a randomized controlled study to evaluate the efficacy and safety of toripalimab plus capecitabine as postoperative adjuvant therapy for patients with resectable advanced extrahepatic biliary tract cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Both men and women aged ≥18 years old were eligible.
- •After radical surgery, postoperative pathological diagnosis of gallbladder cancer and Distal cholangiocarcinoma. TNM staging Ⅱ and above.
- •No systemic treatment before to participate in research;
- •ECOG PS score 0-1 points;
- •The main viscera function is normal, no serious blood, heart, lung, liver, kidney and bone marrow dysfunction, and immune deficiency disease.
- •Laboratory tests meet the following requirements: women of childbearing age must be within 14 days before the group for a pregnancy test results were negative serum or urine, and voluntary in the observation period and the last 8 weeks after with the study drug to adopt the appropriate methods of contraception; In men, either surgical sterilization or consent to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug was given.
- •Patients volunteered for and sign the informed consent;
- •Expect good adherence, can according to the plan calls for follow-up curative effect and adverse reactions.
排除标准
- •Postoperative pathology showed Pancreatic cancer and ampullary cancer;
- •The former group received PD 1, PD - L1, PD patients treated L2, CTLA 4, or directly to another stimulus or common weak T cell receptors (such as CTLA - 4, 0 x40, CD137) patients;
- •Use of any other study medication within 4 weeks before enrollment;
- •Have any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after hormone replacement therapy)); Patients with complete remission of childhood asthma without any intervention in adulthood or with white scarring were eligible, but those requiring medical intervention with bronchodilators were not eligible;
- •People with innate or acquired immune deficiency, such as people with human immunodeficiency virus (HIV) infection;
- •Patients with uncontrolled cardiac clinical symptoms or diseases, such as unstable angina pectoris with NYHA II or higher heart failure, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- •Severe infection (e.g., requiring intravenous antibiotics, antifungal, or antiviral drugs) within 4 weeks before the first dose, or unexplained fever >38.5°C during screening/before the first dose;
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Live attenuated vaccine is administered within 4 weeks before the first dose or is planned for the duration of the study;
- •Patients with or accompanied by other systemic malignant tumors within the last 5 years (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and ovarian cancer);
- •Known allergy to any of the trial drugs;
- •Pregnant, lactating women and subjects with reproductive capacity were unwilling to take effective contraceptive measures;
- •Suffering from uncontrollable psychosis; fourteen Other conditions that the investigator deemed inappropriate for inclusion. If the patient has central nervous system metastasis, serious laboratory abnormalities, accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.
研究组 & 干预措施
Toripalimab combined with capecitabine therapy group
Experimental
干预措施: Toripalimab (Drug)
Capecitabine therapy group
Experimental
干预措施: Capecitabine (Drug)
Toripalimab combined with capecitabine therapy group
Experimental
干预措施: Capecitabine (Drug)
结局指标
主要结局
1-year recurrence-free survival rate
时间窗: 1 year
次要结局
- 2-year OS(2-year)
- 1-year OS(1 year)
- Occurrence of adverse reactions(1 year)
研究者
研究点 (1)
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