Panreatic Cancer
Conditions
Interventions
hyperthermic intraperitoneal chemotherapy (HIPEC) plus Systemic Chemotherapy:HIPEC 2 times (cisplatin 70mg/m2) + Systemic Chemotherapy 4 cycles (albumin-bound paclitaxel 125mg/m2 + gemcitabine 1000mg/
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Obtain signed informed consent from the patient or their legal representative, with adherence to the study protocol and follow-up procedures; 2. Aged >=18 and =3.0 × 10?/L; Absolute neutrophil count (ANC) >=1.5 × 10?/L; Platelets (PLT) >=100 × 10?/L; Hemoglobin (Hgb) >=90 g/L. 8. Blood biochemistry criteria: AST (SGOT) and ALT (SGPT) <=2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) <=2 × ULN; Serum creatinine (CRE) <=1.5 × ULN. 9. Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) <=1.5 × ULN; 10. Compliance with study visit schedules and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive evidence, except for ovarian metastases; 2. History of other systemic malignancies within the past five years; 3. Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment; 4. Accompanied by massive ascites (extending from pelvic to upper abdominal cavity); 5. History of upper gastrointestinal bleeding requiring repeated blood transfusions within the past three months; 6. Pregnancy, autoimmune diseases, severe hyperthyroidism/hypothyroidism, central nervous system disorders, psychiatric illnesses, unstable angina, congestive heart failure, severe arrhythmias, or other uncontrolled serious medical conditions; 7. History of hypersensitivity to the study drugs or medications with similar chemical structures; 8. Patients requiring long-term warfarin anticoagulation therapy; 9. Poor compliance, inability or unwillingness to provide signed informed consent; 10. Patients likely to be lost to follow-up for =14 days during the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS,Progression-free survival;ORR,Objective response rate;DCR,Disease control rate;Incidence Rate of Adverse Events ;Pain relief rate in cancer-related abdominal pain;Proportion of patients with malignant ascites; | — |
Countries
China
Contacts
Public ContactLiang Liu
Zhongshan Hospital Fudan University
Outcome results
None listed