NCT01525069终止1 期
Pilot Study of Hepatic Arterial Infusion Therapy in Patients With Unresectable or Borderline Resectable Intrahepatic Cholangiocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities (DLTs)
研究概览
简要总结
This pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (HAI) of floxuridine (FUDR) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. HAI is a method to deliver higher concentrations of FUDR more directly to liver tumors and reduces side effects. HAI alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease. Diagnosis must be histologically or cytologically confirmed for continued treatment on study after pump placement.
- •Patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan/MRI
- •Patient must have disease that is unresectable or borderline resectable with < 70% liver involvement by cancer
- •Patient must be >= 18 years old.
- •Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%)
- •Patient must have normal organ and marrow function as defined below:
- •Absolute neutrophil count >= 1,500/mcL
- •Platelets >= 75,000/mcL
- •Total bilirubin =< 2 mg/dL
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 5 X institutional upper limit of normal
- •Creatinine <= institutional upper limit normal
- •Patient must be able to understand and willing to sign a written informed consent document
排除标准
- •Patients must not have had prior treatment with FUDR
- •Patient must not be receiving any other investigational agents
- •Patient must not have a diagnosis of Gilbert's disease
- •Patient must not have a diagnosis of hepatic encephalopathy
- •Patient must not have had prior external beam radiation to the liver
- •Patient must not have a diagnosis of sclerosing cholangitis
- •Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patient must not be pregnant or breastfeeding
研究组 & 干预措施
Arm A (HAI FUDR alone)
Experimental
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Floxuridine (Drug)
Arm A (HAI FUDR alone)
Experimental
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Dexamethasone (Drug)
Arm B (HAI FUDR + gemcitabine)
Experimental
- Consists of Cohort B1, B2, and B3. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR and gemcitabine.
- Gemcitabine IV will be given on Days 1, 8, and 15 of each 28 day cycle in Cohort B1
- Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle in Cohort B2 & B3
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Floxuridine (Drug)
Arm B (HAI FUDR + gemcitabine)
Experimental
- Consists of Cohort B1, B2, and B3. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR and gemcitabine.
- Gemcitabine IV will be given on Days 1, 8, and 15 of each 28 day cycle in Cohort B1
- Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle in Cohort B2 & B3
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Dexamethasone (Drug)
Arm B (HAI FUDR + gemcitabine)
Experimental
- Consists of Cohort B1, B2, and B3. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR and gemcitabine.
- Gemcitabine IV will be given on Days 1, 8, and 15 of each 28 day cycle in Cohort B1
- Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle in Cohort B2 & B3
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Gemcitabine (Drug)
Arm C (HAI FUDR + gemcitabine + oxaliplatin)
Experimental
- Consists of Cohort C1, C2, C3, and C4. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR, gemcitabine, and oxaliplatin.
- Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle.
- Oxaliplatin IV will be given on Days 1 and 15 of each 28 days cycle.
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Floxuridine (Drug)
Arm C (HAI FUDR + gemcitabine + oxaliplatin)
Experimental
- Consists of Cohort C1, C2, C3, and C4. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR, gemcitabine, and oxaliplatin.
- Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle.
- Oxaliplatin IV will be given on Days 1 and 15 of each 28 days cycle.
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Dexamethasone (Drug)
Arm C (HAI FUDR + gemcitabine + oxaliplatin)
Experimental
- Consists of Cohort C1, C2, C3, and C4. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR, gemcitabine, and oxaliplatin.
- Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle.
- Oxaliplatin IV will be given on Days 1 and 15 of each 28 days cycle.
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Gemcitabine (Drug)
Arm C (HAI FUDR + gemcitabine + oxaliplatin)
Experimental
- Consists of Cohort C1, C2, C3, and C4. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR, gemcitabine, and oxaliplatin.
- Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle.
- Oxaliplatin IV will be given on Days 1 and 15 of each 28 days cycle.
- 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump.
- This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.
- The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs)
时间窗: Completion of 2 cycles of treatment by all patients (approximately 4 years)
Document the frequency of grades 3-5 non-hematologic toxicities (dose-limiting toxicities) associated with the treatment regimen by patient and by type of toxicity for each cohort during the first 2 cycles of treatment
次要结局
- Overall survival(Up to 5 years)
- Number and grade of adverse events(Beginning with pump placement and continuing for 30 days following the last day of study treatment (median length of treatment 3 months))
- Time to progression (TTP)(24 months)
- Response rates(8 weeks)
- Imaging biomarkers of tumor response(Pre-treatment and then every 8 weeks during treatment (median length of treatment 3 months))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
pilot study of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma patients in Child-Pugh score 8,9advanced hepatocellular carcinomaJPRN-UMIN000009272Department of Gastroenterology and Metabolism,Hiroshima University Hospital30
已完成
2 期
Study of Hepatic Arterial Infusion to Treat Biliary Tract CarcinomasBiliary Tract CancerNCT01572324Peking University37
已完成
不适用
Pilot study of hepatic arterial infusion chemotherapy followed by sorafenib for advanced hepatocellular carcinomaadvanced hepatocellular carcinomaJPRN-UMIN000009094Department of Gastroenterology and Metabolism,Hiroshima University Hospital55
已完成
1 期
Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver MetastasesMetastatic Uveal MelanomaMetastatic Cutaneous MelanomaNCT04812470Vastra Gotaland Region8
招募中
2 期
A Trial of Hepatic Arterial Infusion Combined With Apatinib and Camrelizumab for C-staged Hepatocellular Carcinoma in BCLC ClassificationC-staged Hepatocellular Carcinoma in BCLC ClassificationNCT04191889Sun Yat-sen University47