Effectiveness and Safety Evaluation of Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis: A Prospective, Single-center, Single-arm, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This study is a prospective, single center, single arm, phase II clinical study in patients with liver metastasis after radical resection of pancreatic cancer. The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
详细描述
Microwave ablation, as one of the important treatment methods of liver metastases, has the advantages of radical effect, small trauma and rapid recovery.Microwave ablation combined with chemotherapy aims to improve the quality of life and prolong the survival time.The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
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: 18 to 75years old, male or female;
- •ECOG PS: 0-2 points;
- •Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;
- •Expected survival time> 3 months;
- •The functions of important organs meet the following requirements;
- •The maximum diameter of single lesion ≤ 5cm or the number of multiple lesions ≤ 5 and the maximum diameter ≤ 3cm;
- •Measurable lesions that meet RECIST criteria.
- •Platelet ≥75×109/L, hemoglobin ≥85g/L，white blood cell ≥ 3.0 × 109 / L;
- •Total bilirubin ≤ 1.5 times upper limit of normal value (ULN) ; ALT and AST ≤ 5 times ULN ;
- •Albumin ≥ 28g / L;
- •Creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 50ml / min;
- •Women of childbearing age must undergo a negative pregnancy test (βHCG) before starting treatment. Women and men of childbearing age (sexual relationships with women of childbearing age) must agree to use them effectively during treatment and 3 months after the last dose of treatment Contraceptive measures;
- •Signature of patient information and informed consent.
- •Patients who did not participate in other clinical trials within 4 weeks before screening; those who failed in other trials but met the requirements of this trial could be enrolled.
排除标准
- •Patients with distant metastasis include but not limited to lung metastasis, bone metastasis and brain metastasis;
- •Other serious diseases or conditions, including congestive heart failure (NYHA grade III or IV), unstable angina, myocardial infarction and cerebral infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, drug abuse, etc;
- •Women who are pregnant or nursing, or have fertility but refuse to take contraceptive measures;
- •During the enrollment period, a serious active infection requiring antibiotic intravenous treatment occurred;
- •In addition to cervical carcinoma in situ, basal cell carcinoma and superficial bladder tumor (TA, tis & T1). Any cancer cured for more than 3 years before enrollment was allowed to be enrolled;
- •Patients who cannot follow the trial protocol or cannot cooperate with follow-up;
结局指标
主要结局
OS
时间窗: 24months
Overall survival
次要结局
- DCR(From the first drug administration up to two years)
- 6-month PFS(6months)
- ORR(From the first drug administration up to two years)
- Complete ablation rate(From the first drug administration up to two years)