Status:
UNKNOWN
Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy
Lead Sponsor:
Fudan University
Conditions:
Advanced Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
In view of the existence of malignant ascites in patients with advanced pancreatic cancer, we put forward the heat abdominal cavity perfusion chemotherapy combined albumin paclitaxel and gemcitabine c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04707118
Start Date
February 23 2021
End Date
December 30 2022
Last Update
January 13 2021
Active Locations (1)
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1
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Sahnghai, China, 200032