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NCT05222204CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 22 May 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
91 (actual)
First submitted
14 Sept 2021
Start date
15 May 2022
Primary completion date
8 Jul 2024
Lead sponsor
Fudan University
NCT number
NCT05222204

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 91
  • From 15 May 2022 to the primary completion date, 8 Jul 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have used any other study drug within 7 days before chemotherapy;

Other illness

  • Associated with other systemic malignant tumors;
  • 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;

Other

  • Patients were excluded from the study if they met any of the following criteria:
  • Single kidney, deformed kidney or poor renal compensation;
  • Patients who are using and require long-term use of warfarin anticoagulation.

Who the study is looking for

  • 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.
  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.