NCT04111380Unknown2 期
Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers: a Prospective, Open Label, Single-arm Phase II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate [ORR]
研究概览
简要总结
To verify the role of nab-paclitaxel in second or later-line treatment in advanced biliary tract cancers, the investigators designed a prospective, exploratory, single arm,single center phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as second or later-line treatment in advanced biliary tract cancers.
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
- •Age ranges from 18 to 75 years
- •Radiographically, histologically or/and cytologically diagnosed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer.
- •Received at least one first-line systemic treatment for advanced or metastatic diseases and failed, with imaging evidence of disease progression.
- •ECOG performance status 0-1
- •According to the RECIST1.1 standard, at least one measurable objective lesion should be judged.
- •Expected survival more than 12 weeks
- •The laboratory test meet the following requirements:
- •Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5x ULN；AST and ALT) ≤ 2.5x ULN Renal function：Cr ≤ 1.5x ULN，Ccr ≥ 45 ml/min Coagulation function：INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range
- •Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver).
- •During the non-lactation period, contraceptive measures should be taken in patients of child-bearing age during this trial. The test ofβ- HCG was negative.
- •The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form
排除标准
- •With Chemotherapy contraindication, known to be allergic, highly sensitive or intolerable to research-related drugs or excipient.
- •Pregnant or lactating women.
- •Refuse or fail to sign informed consent to participate in the trial
- •Grade 2 or above peripheral neuropathy or hemorrhage according to NCI CTCAE 4.03
- •Combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(BP≥160/95mmHg), unstable angina, a history of myocardial infarction in the past 6 months,Congestive heart failure>NYHA grade II, severe arrhythmia, pericardial effusion, etc.
- •Patients with severe systemic infections or other serious diseases.
- •Combined with other primary tumors
- •Patients not suitable for the group according to the judgement of the researcher, with mental disease.
- •Patients with symptomatic central nervous system (CNS) metastases who require radiotherapy, surgery or sustained corticosteroid use, and untreated brain metastases that cause any symptoms
- •Prior exposure to nab-paclitaxel
- •The investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent.
研究组 & 干预措施
Nab-paclitaxel and Cisplatin
Experimental
cisplatin and nab-paclitaxel: Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.
干预措施: cisplatin and nab-paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate [ORR]
时间窗: 2 years
次要结局
- adverse events(2 years)
- Disease Control Rate [DCR](2 years)
- Progression Free Survival [PFS](2 years)
- Overall survival [OS](2 years)
研究者
研究点 (1)
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