Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

Fudan University

Status and phase

Unknown

Phase 1

Conditions

Advanced Pancreatic Cancer

Treatments

Drug: cisplatin+Nab-paclitaxel+GEM

Drug: Nab-paclitaxel+GEM

Study type

Interventional

Funder types

Other

Identifiers

NCT04707118

CSPAC-30

Details and patient eligibility

About

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.

Enrollment

106 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

106 participants in 2 patient groups

Thermal perfusion cisplatin+Nab-paclitaxel+GEM

Experimental group

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

Treatment:

Drug: cisplatin+Nab-paclitaxel+GEM

Nab-paclitaxel+GEM

Active Comparator group

Description:

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

Treatment:

Drug: Nab-paclitaxel+GEM