Gemcitabine and Nab-paclitaxel Venous Injection Plus Transcatheter Arterial Infusion to Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall survival，OS
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to Patients with Advanced Pancreatic Cancer.
详细描述
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The MPACT trial has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.
Regional intra-arterial infusion chemotherapy helps to deliver anticancer drugs into the carcinoma tissue more selectively and is considered to be a potential alternative treatment for advanced pancreatic adenocarcinoma with less systemic adverse effects. Ohigashi et al first reported that intraarterial chemotherapy using 5-fluorouracil improved the prognosis and quality of life in patients with advanced pancreatic carcinoma.
The purpose of this study is to evaluate the efficacy of gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion to patients with advanced pancreatic cancer. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.
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
- •Ability to understand and the willingness to sign a written informed consent document.
- •Age ≥ 18 years and ≤ 80 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
- •Primary pancreatic cancer without major anti-cancer treatments.
- •Locally advanced, or metastatic pancreatic cancer.
- •Presence of at least of one measurable lesion in agreement to RECIST criteria.
- •The expected survival ≥ 3 months.
- •Adequate organ performance based on laboratory blood tests.
- •Patients who are willing or able to comply with study procedures.
排除标准
- •Pregnant or nursing women.
- •Patients who have received anti-tumor chemotherapy, radiotherapy, or other treatments.
- •The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- •Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- •Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
- •Cardiovascular and cerebrovascular accidents.
- •Allergic to study drugs.
- •Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
研究组 & 干预措施
gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1 (venous injection), 8 (venous injection), and 15 (transcatheter arterial infusion) every 4 weeks.
干预措施: Gemcitabine (Drug)
gemcitabine and nab-paclitaxel venous injection plus transcatheter arterial infusion
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1 (venous injection), 8 (venous injection), and 15 (transcatheter arterial infusion) every 4 weeks.
干预措施: Nab paclitaxel (Drug)
结局指标
主要结局
Overall survival，OS
时间窗: At the end of Cycle 1 (each cycle is 28 days)
OS of subjects from recruiting to the time of death from any cause
次要结局
- disease control rate (DCR)(At the end of Cycle 1 (each cycle is 28 days))
- progression-free survival, PFS(At the end of Cycle 1 (each cycle is 28 days))
- objective response rate (ORR),(At the end of Cycle 1 (each cycle is 28 days))