Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

Recruitment & Eligibility

Inclusion Criteria

Participate voluntarily and sign informed consent;
Age ≥18 years old and ≤80 years old, regardless of gender;
Physical condition ECOG 0 ~ 2;
The diagnosis of pancreatic adenocarcinoma was confirmed by pathology;
Peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy;
Expected survival ≥3 months;
No serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards);
Blood routine indicators: white blood cell (WBC) ≥3 × 109/L;Absolute count of neutrophils (ANC) ≥1.5 × 109/L;Platelet (PLT) ≥100 × 109/L;Hemoglobin (Hgb) ≥9 g/dL;
Blood biochemical indexes: AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of normal value (ULN);Total bilirubin (TBIL) ≤ULN;Serum creatinine (CRE) ≤1.5 × ULN;
Coagulation function: Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN;
Comply with the study visit plan and other program requirements.

Exclusion Criteria

Accompanied by other systemic malignant tumors;
Received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy;
Used any other study drugs within 5 weeks before enrollment;
Central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected.
A history of allergy to study drugs or similar structured drugs;
Pregnant or lactating women;
Any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data;
Intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.

Study & Design

Arm && Interventions

Group	Intervention	Description
Nab-paclitaxel+GEM	Nab-paclitaxel+GEM	Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles
Thermal perfusion cisplatin+Nab-paclitaxel+GEM	cisplatin+Nab-paclitaxel+GEM	Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles

Primary Outcome Measures

Name	Time	Method
Ascites control	4 weeks	The change of abdominal volume of subjects from enrollment.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility