DDP ip Combined With AG in PDAC With Peritoneal Metastasis

Study Overview
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Brief Summary
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intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis

Official Title
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Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis

Conditions
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Pancreatic Neoplasm

Intervention / Treatment
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* Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; The imaging assessment is abdominal metastasis or peritoneal thickening; or CA199/CA125 is elevated in the course of the disease but no other solid organ metastasis is found; 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: two cohort: cohort A (first-line) and cohort B (post-line)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IP<br>intravenous AG+ IP cisplatin | Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel<br>* intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | patients the time from enrollment to death from any cause | 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 |