Status:
RECRUITING
The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Hyperthermic Intraperitoneal Chemotherapy
Peritoneal Metastatic Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of hyperthermic intraperitoneal chemotherapy combined with intravenous chemotherapy in peritoneal metastatic pancreatic canc...
Eligibility Criteria
Inclusion
- Obtain signed informed consent from the patient or their legal representative, with adherence to the study protocol and follow-up procedures;
- Aged \>=18 and \<=80 years, regardless of gender;
- No contraindications to surgery, with an ECOG performance status of 0-1;
- Confirmed peritoneal metastasis by imaging or intraoperative detection, with rapid intraoperative histopathology indicating metastatic adenocarcinoma;
- No prior anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-intensity focused ultrasound (HIFU), radiotherapy, immunotherapy, molecular targeted therapy, or traditional Chinese medicine anti-tumor treatments;
- No severe hematological, cardiac, pulmonary dysfunction, or autoimmune deficiency (based on respective diagnostic criteria);
- Hematological criteria: White blood cells (WBC) \>=3.0 × 10⁹/L; Absolute neutrophil count (ANC) \>=1.5 × 10⁹/L; Platelets (PLT) \>=100 × 10⁹/L; Hemoglobin (Hgb) \>=90 g/L.
- 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.
- Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) \<=1.5 × ULN;
- Compliance with study visit schedules and other protocol requirements.
Exclusion
- Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive evidence, except for ovarian metastases;
- History of other systemic malignancies within the past five years;
- Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment;
- Accompanied by massive ascites (extending from pelvic to upper abdominal cavity);
- History of upper gastrointestinal bleeding requiring repeated blood transfusions within the past three months;
- 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;
- History of hypersensitivity to the study drugs or medications with similar chemical structures;
- Patients requiring long-term warfarin anticoagulation therapy;
- Poor compliance, inability or unwillingness to provide signed informed consent;
- Patients likely to be lost to follow-up for ≥14 days during the treatment period.
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06946901
Start Date
April 3 2025
End Date
December 31 2027
Last Update
April 27 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000