A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- (Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
研究概览
简要总结
Objective Primary:
Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen
Secondary:
Determine time to progression-free survival and overall survival of patients treated with this regimen.
Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen
详细描述
Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study
Chemotherapy regimen:
Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total
Patients: A total of 260 patients (130 per group) will be accrued for this study.
Patients distribution:
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
- •Patients with unresectable locally advanced disease or unresectable local recurrence, including:
- •Patients with unresectable advanced gallbladder cancer （≥ Nevin staging IV or TNM（ tumor node metastasis） classification）
- •Patients with complication who have no indication for surgery
- •Patients with unresectable local recurrence lesions
- •Age between 18-75, no gender-based constraints
- •Estimated life expectancy ≥12 weeks
- •KPS（Karnofsky performance status ）≥60
- •Each patient gave written informed consent
- •< 2 previous chemotherapy regimes
- •No chemotherapy done in the last 4 weeks
- •Laboratory test criteria:Haemoglobin ≥ 10g/dl, white blood cell count > 3,000/mm3 ;Platelet >100,000/mm3 Total bilirubin <5.0mg/dl ALT（alanine transaminase）、 AST（aspartate aminotransferase)≤ 2.5 times upper limit of normal BUN（blood urea nitrogen）≤ 2 times upper limit of normal; serum creatinine <1.5mg/dl: creatinine clearance rate < 60 ml/min
- •Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound
- •Jaundice should be reduced to standard level before chemotherapy (Total bilirubin <5.0 mg/dl)
排除标准
- •Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy
- •Patients who are pregnant or breastfeeding.
- •Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy
- •Patients who had a history of previous carcinoma in the last 5 years.
- •Patients who are allergic to somatostatin or fluorouracil
- •Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.
研究组 & 干预措施
Somatotatin
Conventional chemotherapy regimen plus somatostatin
干预措施: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil） (Drug)
epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil)
conventional regimen
干预措施: epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil） (Drug)
Somatotatin
Conventional chemotherapy regimen plus somatostatin
干预措施: Somatostatin (Drug)
结局指标
主要结局
(Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
时间窗: 6 month after first treatment
次要结局
- A: KPS (karnofsky performance score) B:Laboratory tests: Reexamination of CA19-9（Carbohydrate Antigen 19-9）、 CEA（ carcinoembryonic antigen）, especially for those which are abnormal prior to chemotherapy(6 month after first treatment)
研究者
Zhi-wei Quan
Professor
Shanghai Jiao Tong University School of Medicine