Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

NCT ID: NCT04707118

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2022-12-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

cisplatin+Nab-paclitaxel+GEM

Intervention Type: 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

Nab-paclitaxel+GEM

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

Group Type: ACTIVE_COMPARATOR

Nab-paclitaxel+GEM

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Nab-paclitaxel+GEM

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

President of Shanghai Pancreatic Cancer Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Sahnghai, China

Countries

China

Central Contacts

xianjun YU, PhD

Role: CONTACT

yuxianjun@fudanpci.org

18019112906

Facility Contacts

Xianjun Yu, Phd

Role: primary

Other Identifiers

CSPAC-30

Identifier Type: -

Identifier Source: org_study_id