Actively Recruiting
Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis
Led by Mayo Clinic · Updated on 2025-12-16
40
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as nab-paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.
CONDITIONS
Official Title
Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Cytologic or histologic proof of pancreatic adenocarcinoma
- Leukocyte count at least 3,000/uL
- Absolute neutrophil count at least 1,500/uL
- Platelet count at least 60,000/uL
- Serum creatinine 1.5 mg/dL or less
- Presence of distant metastatic disease limited to peritoneum confirmed by positive peritoneal cytology, limited carcinomatosis on laparoscopy or laparotomy, or positive KRASD assay on peritoneal washings/cytology
- Completion of preoperative systemic chemotherapy with biochemical, metabolic, or radiographic response defined as a reduction in baseline CA 19-9 by more than 50%, or radiographic/metabolic response by RECIST 1.1 or PERCIST criteria
- Peritoneal Carcinomatosis Index (PCI) 7 or less with surgeon's assessment of high likelihood for complete cytoreduction
You will not qualify if you...
- Metastatic disease outside the peritoneum such as liver, central nervous system, or lung metastases
- Infections like pneumonia or wound infections that prevent protocol therapy
- Women who are pregnant or of childbearing potential not using adequate contraception
- Inability to comply with study and follow-up procedures
- Known life-threatening hypersensitivity to protocol systemic chemotherapy requiring hospitalization or causing significant disability
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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