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Clinical Trial Record

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DDP ip Combined With AG in PDAC With Peritoneal Metastasis

2022-05-15

2024-07-08

2024-12-12

91

Study Overview

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

N/A

  • Pancreatic Neoplasm
  • DRUG: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel
  • CSPAC-38

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-09-14  

N/A  

2025-05-18  

2022-02-02  

N/A  

2025-05-22  

2022-02-03  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: IP

intravenous AG+ IP cisplatin

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

  • intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
Primary Outcome MeasuresMeasure DescriptionTime Frame
overall survivalpatients the time from enrollment to death from any causeFrom 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
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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