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Hyperthermic Intraperitoneal Chemotherapy for Pancreatic Cancer with Peritoneal Metastasis

This study is looking at a treatment called hyperthermic intraperitoneal chemotherapy (HIPEC) for pancreatic cancer that has spread to the lining of the abdomen (peritoneal metastasis). HIPEC involves delivering heated chemotherapy drugs, specifically nab-paclitaxel and cisplatin, directly into the abdominal area. This is different from standard chemotherapy given through a vein. The goal is to see how well HIPEC works in stopping tumor growth and how safe it is for patients. You might be able to join if you are between 18 and 80 years old, have pancreatic adenocarcinoma that has spread to the peritoneum, and meet certain blood test requirements. The researchers will measure overall survival and how long you live without the cancer getting worse (progression-free survival) for up to 4 years to see if the treatment is successful. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 40 participants. It is a single-arm study, meaning all participants receive the same treatment.
What's involved
You would receive HIPEC with nab-paclitaxel and cisplatin, potentially up to 5 times. You would also undergo CT scans and MRIs during screening and be followed up every 6 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up every 6 months after completing treatment, with overall survival and progression-free survival measured for up to 4 years.

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NCT04858009

Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Mayo Clinic
~40 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:CisplatinHyperthermic Intraperitoneal ChemotherapyNab-paclitaxelComputed TomographyMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival
Measured over Up to 4 years
+1 more outcome measured

Conditions

Metastatic Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v8
Metastatic Malignant Neoplasm in the Peritoneum

Explore related trials

Pancreatic CarcinomaPeritoneal CarcinomatosisGTPase KRas

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Cornelius A. Thiels, DO, MBA · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>= 18 but =\< 80
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
Cytologic or histologic proof of adenocarcinoma of the pancreas
Leukocytes \>= 3,000/uL
Absolute neutrophil count \>= 1,500/uL
Platelets \>= 60,000/Ul
Serum creatinine =\< 1.5 mg/dL
Distant metastatic disease of peritoneum may be visualized on imaging:
Positive peritoneal cytology
Limited carcinomatosis on diagnostic laparoscopy or laparotomy
KRASD assay positive peritoneal washings/cytology
Completion of preoperative systemic chemotherapy with biochemical, metabolic, and/or radiographic response defined as a reduction in the baseline CA 19-9 by \> 50% or radiographic response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or metabolic response on positron emission tomography (PET)-magnetic resonance imaging (MRI) defined by PET Response Criteria in Solid Tumors (PERCIST) criteria
Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeons deems high likelihood for a complete cytoreduction

Exclusion

Distant metastatic disease not limited to peritoneum:
Solid organ metastases (liver, central nervous system, lung)
Infections such as pneumonia or wound infections that would preclude protocol therapy
Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
Subjects deemed unable to comply with study and/or follow-up procedures
Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

What this trial measures

  • Overall survivalUp to 4 years

    Overall survival will be assessed from the date of cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) to death by any cause, regardless of disease recurrence. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient may be contacted by telephone and/or videoconferencing.

  • Progression-free survivalUp to 4 years

    Progression-free survival is will be assessed from the date of cytoreduction and HIPEC to recurrence of tumor or death. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient may be contacted by telephone and/or videoconferencing.