NCT05215665招募中不适用
Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2022年1月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years old ≤ age ≤ 70 years old
- •ECOG PS scores 0-1
- •Expected survival time > 12 weeks
- •Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria)
- •Not received any previous systemic or local treatment for the tumor
- •Sufficient organ and bone marrow function
排除标准
- •Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ)
- •Ampullary tumor
- •Received treatment from other clinical trials within 4 weeks before the first dose
- •Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
- •Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction
- •Uncontrollable pleural effusion, pericardial effusion or ascites
- •Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment
- •Allergic reactions to the drugs used in this study
- •HIV antibody positive, active hepatitis B or C (HBV, HCV)
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- •other conditions that the investigator deems inappropriate for enrollment
研究组 & 干预措施
group 2
Experimental
GEMOX+Toripalimab
干预措施: GEMOX Regimen (Drug)
group 2
Experimental
GEMOX+Toripalimab
干预措施: Toripalimab (Drug)
group 1
Experimental
GEMOX+Lenvatinib+Toripalimab
干预措施: Lenvatinib (Drug)
group 1
Experimental
GEMOX+Lenvatinib+Toripalimab
干预措施: Toripalimab (Drug)
group 1
Experimental
GEMOX+Lenvatinib+Toripalimab
干预措施: GEMOX Regimen (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 90 days after last treatment administration
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
次要结局
- Disease Control Rate (DCR)(up to 90 days after last treatment administration)
- Progression free survival (PFS)(up to 3 years)
- Overall survival (OS)(up to 3 years)
- The frequency, duration, and severity of adverse events(up to 30 days after last treatment administration)
研究者
研究点 (1)
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