A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
详细描述
The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Chinese；
- •Stable vital signs, KPS≥60;
- •Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;
- •Adequate fresh tumor tissue for genome sequencing and immuno- histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;
- •At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;
- •Life expectancy of more than 12 weeks;
- •Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN), AST≤10×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/L, platelets≥80×10^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;
- •Volunteer for this study, have written informed consent and have good Patient compliance;
- •Female patients of childbearing potential and their mates agree to avoid pregnancy.
排除标准
- •Have received following treatment before this study:
- •Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;
- •lesions have been treated by irradiation;
- •participate in other therapeutic or interventional clinical trials. - Page 5 of 5 [DRAFT] -
- •Have central nervous system metastasis;
- •History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
- •Have symptomatic ascites and need for treatment;
- •Have serious concurrent illness including, but not limited to
- •uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure >21.3 Kpa or diastolic blood pressure >13.3 Kpa);
- •ongoing or active serious infection;
- •uncontrolled diabetes mellitus;
- •psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
- •HIV infection;
- •other serious illness considered not suitable for this study by investigators.
- •be allergic or have contraindications to target medicines involved in this study, gemcitabine or oxaliplatin.
研究组 & 干预措施
Chemotherapy
The patients wil receive conventional chemotherapy FORFIRINOX
干预措施: mutation and signal pathway activation status analysis Drug: FORFIRINOX (Biological)
结局指标
主要结局
Progression Free Survival
时间窗: up to 1 year
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.
次要结局
- Overall survival(up to 2 years)
- Objective Response Rate(up to 1 year)
- Disease Control Rate(up to 1 year)
- percentage of patients with Clinical Benefit Response(up to 1 year)
研究者
liu yingbin
head of general surgery department，xin hua Hospital Affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine