Status:
COMPLETED
DDP ip Combined With AG in PDAC With Peritoneal Metastasis
Lead Sponsor:
Fudan University
Conditions:
Pancreatic Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
Eligibility Criteria
Inclusion
- cohort A
- Patients should meet the following criteria before treatment to be included in the trial:
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- ECOG score ≤2 points;
- Pathological diagnosis of pancreatic adenocarcinoma;
- Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis;
- 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;
- No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
- Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
- Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
- Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
- 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:
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- ECOG score ≤2 points;
- Pathological diagnosis of pancreatic adenocarcinoma;
- malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed.
- At least one systemic chemotherapy has been used;
- No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
- Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
- Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
- Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
- Able to comply with research visit plans and other protocol requirements.
Exclusion
- Patients were excluded from the study if they met any of the following criteria:
- Associated with other systemic malignant tumors;
- Single kidney, deformed kidney or poor renal compensation;
- Have used any other study drug within 7 days before chemotherapy;
- Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
- There is a history of allergy to the study drug or drugs of similar structure;
- Patients who are using and require long-term use of warfarin anticoagulation.
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT05222204
Start Date
May 15 2022
End Date
December 12 2024
Last Update
May 22 2025
Active Locations (2)
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1
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032