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Completed

NCT Number: NCT05222204

DDP ip Combined With AG in PDAC With Peritoneal Metastasis

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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 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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. overall survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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