NCT06438822招募中2 期
Second-line Treatment of PD-1 and CTLA-4 Blockade Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma: a Single-arm, Prospective Phase II Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of the combination of cadonilimab with liposomal irinotecan plus fluorouracil and leucovorin for the treatment of advanced 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with pathologically confirmed locally advanced unresectable or metastatic adenocarcinoma of the bile ducts, gallbladder, or cholangiocellular carcinoma, with primary tumors located in the intrahepatic bile ducts, hilar bile ducts, distal bile ducts, or gallbladder;
- •Progression after prior gemcitabine-based systemic chemotherapy and refused or were intolerable to initial treatment with gemcitabine-based chemotherapy regimens;
- •At least one measurable objective lesion of the tumor according to the RECIST version 1.1 criteria, which must have a maximum diameter of ≥1 cm for spiral CT or ≥2 cm for plain CT or MRI; and should be performed within 28 days prior to enrollment;
- •Aged 18 to 75 years old;
- •Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1;
- •Life expectancy of greater than 3 months;
- •Must be able to participate the study voluntarily and sign the informed consent document;
- •Adequate organ and bone marrow function as below:
- •Absolute neutrophil count ≥1.5*109/L , platelet count ≥75*109/L , hemoglobin ≥90g/L; Alanine aminotransferase, and aspartate aminotransferase ≤2.5 × upper limit of normal; Total bilirubin and serum creatinine ≤1.5 × upper limit of normal.
排除标准
- •Disease-free survival within 5 years due to other malignancies (except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •Serious or uncontrolled infectious disease (HIV, HBV DNA > 500IU/ml);
- •Severe uncontrolled acute infection (infection causing a fever of 38℃ or higher)；
- •Severe hepatic or renal insufficiency; or recent history of myocardial infarction (within 3 months)；
- •Current or past autoimmune disease and susceptibility to its reoccurrence;
- •Serious or uncontrolled pleural effusion or ascites;
- •Subjects with a history of active tuberculosis infection within 1 year prior to the first administration of study drug. If in the judgment of the investigator, subjects with more than 1 year prior to the first administration of study drug were considered suitable for enrollment; Subjects with a long history of chronic diarrhea or the presence of complete intestinal obstruction;
- •Subjects requiring systemic therapy with corticosteroids (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of study drug.
- •Combined with other serious medical and surgical conditions that affected organ function;
- •Participated in other clinical trial within 4 weeks;
- •Pregnant or breastfeeding women or subjects of childbearing potential (males or females with less than 1 year of menopause) who were unwilling to use contraception;
- •Subjects with a history of allergic or hypersensitivity reactions to components of the study drug;
结局指标
主要结局
overall response rate (ORR)
时间窗: Up to 2 years
The total number of participants in the intention-to-treat (ITT) population who achieve a complete response (CR) or partial response (PR) will be considered valid, and the statistical results were used to calculate the ORR based on imaging (CT/MRI) using the RECIST v1.1 criteria.
次要结局
未报告次要终点
研究者
Dan Cao
Chief physician
West China Hospital
研究点 (1)
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