pancreatic cancer
Conditions
Interventions
Group 1:intraperitoneal perfusion of albumin paclitaxel
Group 2:intraperitoneal perfusion of albumin paclitaxel
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Newly treated or recurring pancreatic cancer confirmed by pathology, non-resectable, diagnosis combined with pathology and imaging (CT or MRI) comprehensive judgment; 2) Combining imaging (CT or MRI), laboratory tests (serum markers, ascites test, etc.) to diagnose clear peritoneal metastasis: imaging confirmed peritoneal uneven thickening, high enhancement or associated nodules; omental cake or Multiple cords and nodules in the greater omentum; nodular thickening of the mesentery and effusion in the abdominal cavity; positive exfoliated cytology of the peritoneal effusion, etc.; 3) Past anti-tumor systemic treatments (including chemotherapy, radiotherapy, surgery or other research treatments) are not limited; 4) ECOG 0-1 points; 5) Aged 20 to 80 years; 6) Liver and kidney function and blood routine examination results within 1 week before enrollment meet the following conditions: White blood cells (WBC) 3.5-12x10^9/L, neutrophils (ANC) >= 2x10^9/L, hemoglobin (HGB) >= 8.0g/dL, platelets (PLT) >= 100x10^9/L, Serum creatinine (Cr) = 50mL/min, Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <= 150IU/L, No abnormalities in the electrocardiogram; 7) Female patients must not become pregnant during the test period; during the screening of breastfeeding women, the serum and urine pregnancy test must be negative, and must not be breastfeeding; both male and female patients must take reliable contraceptive measures during the test period; 8) The patient participates voluntarily, can sign an informed consent form and complete the test procedures.
Exclusion criteria
Exclusion criteria: 1) Those who are known to be severely allergic to any study drug; 2) Patients with known distant metastases (such as brain, lung, bone or other organs); 3) Primary tumors or peritoneal deposits invade more than half of the digestive tract, non-extensive peritoneal metastasis; 4) The end of adjuvant chemotherapy is less than 6 months; if the previous systemic chemotherapy regimen contains paclitaxel, the time from the last chemotherapy is less than 28 days; 5) Medium-severe contracture of small mesentery, severe peritoneal adhesions 6) Those who have clear contraindications for intraperitoneal perfusion catheterization 7) Obviously impaired blood coagulation mechanism, active bleeding and bleeding tendency; 8) A history of other malignant tumors within 5 years (except for fully treated basal cell carcinoma of the skin and carcinoma in situ of the cervix); 9) Interstitial pneumonia or pulmonary fibrosis; 10) Uncontrollable pleural effusion or ascites; 11) Patients with severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months); 12) Pregnant or lactating women; 13) Researchers believe that they are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicities (DLT);maximum tolerated dose (MTD);AUC ascites/ AUC plasma; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ascites or peritoneal nodules remission rate;ORR;PFS;OS; | — |
Countries
China
Contacts
Public ContactDan Cao
West China Hospital, Sichuan University
Outcome results
None listed