Clinical trial NCT04707118: Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy
Official title: Peritoneal Perfusion Chemotherapy Combined With Gemcitabine and Albumin Binding Paclitaxel Versus Gemcitabine and Albumin Binding Paclitaxel in the Treatment of Advanced Pancreatic Cancer With Intraperitoneal Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Pancreatic Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 compared with albumin paclitaxel and gemcitabine prospective clinical study, to assess abdominal albumin hot perfusion chemotherapy combined control of ascites and taxol in improving patients' quality of life, survival, exploring the feasibility of celiac hot perfusion chemotherapy combined albumin paclitaxel and side effects.


Eligibility criteria: 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.

Primary outcomes:
measure: Ascites control
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Sahnghai
Study officials:
References: