Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

Advanced Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04707118
• Other study ID #: CSPAC-30
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 23, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2021
• Source: Fudan University
• Contact: xianjun YU, PhD
• Phone: 18019112906
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Sahnghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascites control	The change of abdominal volume of subjects from enrollment.	4 weeks