Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis

Recruitment & Eligibility

Inclusion Criteria

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.
1. Platelet ≥75×109/L, hemoglobin ≥85g/L，white blood cell ≥ 3.0 × 109 / L;
2. Total bilirubin ≤ 1.5 times upper limit of normal value (ULN) ; ALT and AST ≤ 5 times ULN ;
3. Albumin ≥ 28g / L;
4. 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.

Exclusion Criteria

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;

Study & Design

Arm && Interventions

Group	Intervention	Description
Microwave Ablation Combined with Chemotherapy	Microwave Ablation combination with chemotherapy	All patients will receive microwave ablation of oligohepatic metastasis and chemotherapy according to NCCN guidelines,and the efficacy was evaluated every 8 weeks until the disease progressed or the patient could not tolerate it.

Primary Outcome Measures

Name	Time	Method
OS	24months	Overall survival

Secondary Outcome Measures

Name	Time	Method
DCR	From the first drug administration up to two years	Disease Control Rate
6-month PFS	6months	From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
ORR	From the first drug administration up to two years	Overall Response Rate
Complete ablation rate	From the first drug administration up to two years	The complete ablation rate was evaluated by abdominal enhanced MRI or CT at 4 weeks after operation

Recruitment & Eligibility