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DDP ip Combined With AG in PDAC With Peritoneal Metastasis

Primary Purpose

Pancreatic Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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. 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;
  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.

Sites / Locations

  • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan UniversityRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IP

Arm Description

intravenous AG+ IP cisplatin

Outcomes

Primary Outcome Measures

overall survival
patients the time from enrollment to death from any cause

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
February 2, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05222204
Brief Title
DDP ip Combined With AG in PDAC With Peritoneal Metastasis
Official Title
Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
July 2, 2023 (Anticipated)
Study Completion Date
July 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
two cohort: cohort A (first-line) and cohort B (post-line)
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IP
Arm Type
Experimental
Arm Description
intravenous AG+ IP cisplatin
Intervention Type
Drug
Intervention Name(s)
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel
Intervention Description
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
Primary Outcome Measure Information:
Title
overall survival
Description
patients the time from enrollment to death from any cause
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XianJun Yu, M.D., Ph.D.
Phone
+86-21-6417-5590
Email
yuxianjun@fudanpci.org
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, M.D., Ph.D.
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xianjun yu, MD
Phone
64175590
Email
xianjunyu@fudanpci.org
First Name & Middle Initial & Last Name & Degree
heli GAO, MD
Phone
64175590
Email
gaoheli@fudanpci.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
intravenous Gemcitabine+ Nab-paclitaxel combined with IP cisplatin in patients with PDAC with peritoneal metastasis

Learn more about this trial

DDP ip Combined With AG in PDAC With Peritoneal Metastasis

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