Pancreatic Neoplasm
Conditions
Brief summary
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
Interventions
DRUGintraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two cohort: cohort A (first-line) and cohort B (post-line with malignant ascites )
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
cohort A Patients should meet the following criteria before treatment to be included in the trial: 1. Voluntarily participate and sign the informed consent; 2. Age ≥18 years old and ≤75 years old, gender is not limited; 3. ECOG score ≤2 points; 4. Pathological diagnosis of pancreatic adenocarcinoma; 5. Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis; 6. The time from the end of adjuvant chemotherapy after surgery is more than 6 months, or they have not received any form of anti-tumor therapy before, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy; 7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards); 8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL; 9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN; 10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN; 11. Able to comply with research visit plans and other protocol requirements. inclusion criteria (Cohort B) Patients should meet the following criteria before treatment to be included in the trial: 1. Voluntarily participate and sign the informed consent; 2. Age ≥18 years old and ≤75 years old, gender is not limited; 3. ECOG score ≤2 points; 4. Pathological diagnosis of pancreatic adenocarcinoma; 5. malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed. 6. At least one systemic chemotherapy has been used; 7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards); 8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL; 9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN; 10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN; 11. Able to comply with research visit plans and other protocol requirements.
Exclusion criteria
Patients were excluded from the study if they met any of the following criteria: 1. Associated with other systemic malignant tumors; 2. Single kidney, deformed kidney or poor renal compensation; 3. Have used any other study drug within 7 days before chemotherapy; 4. Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled; 5. There is a history of allergy to the study drug or drugs of similar structure; 6. Patients who are using and require long-term use of warfarin anticoagulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | patients the time from enrollment to death from any cause |
Countries
China
Outcome results
None listed