Heated chemotherapy shows promise for advanced pancreatic cancer
NCT ID NCT04858009
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This phase II trial tests a treatment called HIPEC, where heated chemotherapy drugs are placed directly into the abdomen during surgery. It is for people with pancreatic cancer that has spread to the lining of the abdomen. The study will enroll 40 participants to see if this approach can improve survival and control the cancer safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- heated chemotherapy (cisplatin and nab-paclitaxel) delivered directly into the abdomen
- What this could lead to
- If it works, this could offer a new treatment option to control pancreatic cancer that has spread to the abdomen, potentially extending survival.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. Heated chemotherapy carries risks like infection, organ damage, and side effects from the drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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