DDP ip Combined With AG in PDAC With Peritoneal Metastasis

Fudan University

Status and phase: Completed; Phase 2

Conditions: Pancreatic Neoplasm

Treatments: Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT05222204

CSPAC-38

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

IP

Experimental group

Description:

intravenous AG+ IP cisplatin

Treatment:

Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel