Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

NCT04707118 | Unknown Phase 1

• 1 other identifier: CSPAC-30
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Ascites control

  The change of abdominal volume of subjects from enrollment.

  4 weeks

Study Arms (2)

Thermal perfusion cisplatin+Nab-paclitaxel+GEM

EXPERIMENTAL

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

Nab-paclitaxel+GEM

ACTIVE COMPARATOR

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

Drug: Nab-paclitaxel+GEM

Interventions

cisplatin+Nab-paclitaxel+GEM DRUG

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

Thermal perfusion cisplatin+Nab-paclitaxel+GEM

Nab-paclitaxel+GEM DRUG

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

Nab-paclitaxel+GEM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Sahnghai, 200032, China

Location

Central Study Contacts

xianjun YU, PhD

CONTACT

18019112906; yuxianjun@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Shanghai Pancreatic Cancer Institute

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 13, 2021
• Study Start: February 23, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)