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Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

Primary Purpose

Advanced Pancreatic Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
cisplatin+Nab-paclitaxel+GEM
Nab-paclitaxel+GEM
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participate voluntarily and sign informed consent;
  • Age ≥18 years old and ≤80 years old, regardless of gender;
  • Physical condition ECOG 0 ~ 2;
  • The diagnosis of pancreatic adenocarcinoma was confirmed by pathology;
  • Peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy;
  • Expected survival ≥3 months;
  • No serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards);
  • Blood routine indicators: white blood cell (WBC) ≥3 × 109/L;Absolute count of neutrophils (ANC) ≥1.5 × 109/L;Platelet (PLT) ≥100 × 109/L;Hemoglobin (Hgb) ≥9 g/dL;
  • Blood biochemical indexes: AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of normal value (ULN);Total bilirubin (TBIL) ≤ULN;Serum creatinine (CRE) ≤1.5 × ULN;
  • Coagulation function: Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN;
  • Comply with the study visit plan and other program requirements.

Exclusion Criteria:

  • Accompanied by other systemic malignant tumors;
  • Received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy;
  • Used any other study drugs within 5 weeks before enrollment;
  • Central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
  • Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected.
  • A history of allergy to study drugs or similar structured drugs;
  • Pregnant or lactating women;
  • Any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data;
  • Intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.

Sites / Locations

  • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thermal perfusion cisplatin+Nab-paclitaxel+GEM

Nab-paclitaxel+GEM

Arm Description

Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles

Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles

Outcomes

Primary Outcome Measures

Ascites control
The change of abdominal volume of subjects from enrollment.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2021
Last Updated
January 10, 2021
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04707118
Brief Title
Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy
Official Title
Peritoneal Perfusion Chemotherapy Combined With Gemcitabine and Albumin Binding Paclitaxel Versus Gemcitabine and Albumin Binding Paclitaxel in the Treatment of Advanced Pancreatic Cancer With Intraperitoneal Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (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
In view of the existence of malignant ascites in patients with advanced pancreatic cancer, we put forward the heat abdominal cavity perfusion chemotherapy combined albumin paclitaxel and gemcitabine compared with albumin paclitaxel and gemcitabine prospective clinical study, to assess abdominal albumin hot perfusion chemotherapy combined control of ascites and taxol in improving patients' quality of life, survival, exploring the feasibility of celiac hot perfusion chemotherapy combined albumin paclitaxel and side effects.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thermal perfusion cisplatin+Nab-paclitaxel+GEM
Arm Type
Experimental
Arm Description
Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles
Arm Title
Nab-paclitaxel+GEM
Arm Type
Active Comparator
Arm Description
Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin+Nab-paclitaxel+GEM
Intervention Description
Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel+GEM
Intervention Description
Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles
Primary Outcome Measure Information:
Title
Ascites control
Description
The change of abdominal volume of subjects from enrollment.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participate voluntarily and sign informed consent; Age ≥18 years old and ≤80 years old, regardless of gender; Physical condition ECOG 0 ~ 2; The diagnosis of pancreatic adenocarcinoma was confirmed by pathology; Peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy; Expected survival ≥3 months; No serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards); Blood routine indicators: white blood cell (WBC) ≥3 × 109/L;Absolute count of neutrophils (ANC) ≥1.5 × 109/L;Platelet (PLT) ≥100 × 109/L;Hemoglobin (Hgb) ≥9 g/dL; Blood biochemical indexes: AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of normal value (ULN);Total bilirubin (TBIL) ≤ULN;Serum creatinine (CRE) ≤1.5 × ULN; Coagulation function: Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN; Comply with the study visit plan and other program requirements. Exclusion Criteria: Accompanied by other systemic malignant tumors; Received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy; Used any other study drugs within 5 weeks before enrollment; Central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled; Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected. A history of allergy to study drugs or similar structured drugs; Pregnant or lactating women; Any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data; Intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xianjun YU, PhD
Phone
18019112906
Email
yuxianjun@fudanpci.org
Facility Information:
Facility Name
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
City
Shanghai
State/Province
Sahnghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, Phd

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

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