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Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04707118
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
22.2
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 23, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thermal perfusion cisplatin+Nab-paclitaxel+GEM

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

Drug: cisplatin+Nab-paclitaxel+GEM
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
Active Comparator: Nab-paclitaxel+GEM

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

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

Outcome Measures

Primary Outcome Measures

  1. Ascites control [4 weeks]

    The change of abdominal volume of subjects from enrollment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University Shanghai Sahnghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xian-Jun Yu, President of Shanghai Pancreatic Cancer Institute, Fudan University
ClinicalTrials.gov Identifier:
NCT04707118
Other Study ID Numbers:
  • CSPAC-30
First Posted:
Jan 13, 2021
Last Update Posted:
Jan 13, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pancreatic Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Jan 13, 2021