Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.
详细描述
There's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients.
Previous study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion.
So the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
- •Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）;
- •The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
- •Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks;
- •Normal liver,kidney and bone marrow function；
- •Subjects who understand and voluntarily signed a written informed consent form.
排除标准
- •History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis
- •There is any contraindication to use Bortezomib
- •Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
- •A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
- •Pregnant or lactating women.
- •History of radiation within 4 weeks prior to enrollment.
研究组 & 干预措施
Bortezomib treatment
'Bortezomib Injectable Solution
干预措施: Bortezomib (Drug)
结局指标
主要结局
Objective response rate
时间窗: at least 2 months
Objective response rate include response from stable disease to complete response based on RECIST 1.1
次要结局
- changes of platelet count(7 days)
- occurrence of peripheral neuritis(7 days)
研究者
Zhengang Yuan
Director of Oncology Department
Eastern Hepatobiliary Surgery Hospital