Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT04858009

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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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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