NCT05251662招募中2 期
A Phase II Study of Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX as First-line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年1月13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
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Overall response rate ( ORR)
研究概览
简要总结
A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent should be signed before implementing any trial-related procedures
- •Male or female, 18 years old ≤ age ≤ 75 years old
- •Histopathologically or cytologically diagnosed as locally advanced intrahepatic cholangiocarcinoma
- •No previous systemic treatment, More than 6 months after the end of postoperative adjuvant therapy was allowed
- •Expected survival time > 3 months
- •At least ≥ 1 measurable lesions per RECIST 1.1
- •ECOG PS scores 0-2
- •Sufficient organ and bone marrow function
- •Urine or serum pregnancy test is negative
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
experimental group1
Experimental
Sintilimab Combined With GEMOX + IBI305
干预措施: Sintilimab (Drug)
experimental group1
Experimental
Sintilimab Combined With GEMOX + IBI305
干预措施: IBI305 (Drug)
experimental group1
Experimental
Sintilimab Combined With GEMOX + IBI305
干预措施: GEMOX (Drug)
experimental group2
Experimental
Sintilimab Combined With GEMOX
干预措施: Sintilimab (Drug)
experimental group2
Experimental
Sintilimab Combined With GEMOX
干预措施: GEMOX (Drug)
Comparator
Active Comparator
GEMOX
干预措施: GEMOX (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)
- Overall survival (OS)(up to 3 years)
- Progression free survival (PFS)(up to 3 years)
- Adverse event(up to 30 days after last treatment administration)
研究者
研究点 (1)
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