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Led by Mayo Clinic · Updated on 2025-12-16
40
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating hyperthermic intraperitoneal chemotherapy HIPEC for treating patients with pancreatic cancer that has spread to the abdominal area, known as peritoneal metastasis. This phase II trial aims to assess overall survival and disease-free survival in patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology. The study also looks at morbidity outcomes to understand the safety of HIPEC in this group. Participants receive HIPEC treatment combining nab-paclitaxel and cisplatin heated and delivered directly into the abdomen over 90 minutes. Depending on tolerance and disease progression, patients may receive up to five additional HIPEC treatments with paclitaxel and cisplatin. Before treatment, patients undergo imaging scans such as CT, MRI, or PET to assess their condition. During the study, patients are followed every six months after completing treatment to monitor health outcomes. Assessments include imaging scans and clinical evaluations to measure survival and disease progression over up to four years. Safety is monitored by tracking morbidity for 30 days and up to four years. This comprehensive follow-up helps researchers understand the long-term effects of HIPEC for pancreatic cancer with peritoneal spread.
CONDITIONS
Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis
C
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | HIPEC with Cytoreductive Surgery | Systemic Chemotherapy (Standard Care) |
|---|---|---|
| What it is | A combination of surgery to remove visible peritoneal tumors (cytoreduction) followed by heated chemotherapy (HIPEC) containing cisplatin, mitomycin, and nab-paclitaxel directly administered into the abdominal cavity. | Ongoing systemic chemotherapy using established regimens such as FOLFIRINOX or gemcitabine plus nab-paclitaxel for metastatic pancreatic cancer with peritoneal involvement. |
| Role in study or care | Investigational therapy given after preoperative chemotherapy, in patients achieving a partial response. | Systemic chemotherapy remains the standard ongoing treatment for those who do not enter surgical trials or are not HIPEC candidates. |
| Primary use | Studied for possible survival benefit and local tumor control after disease response with prior systemic therapy. | To delay disease progression, relieve symptoms, and prolong survival for metastatic pancreatic cancer. |
| How it is given or performed | Performed in the operating room after cytoreductive surgery; heated chemotherapy agents are delivered into the abdominal cavity, usually for a set duration under anesthesia. | Administered intravenously in an outpatient, infusion center, or clinic setting, on a regular schedule depending on the chemotherapy regimen. |
| Evidence status | Limited evidence from small studies and case series; larger, methodologically robust trials are ongoing. Benefits and risks remain under investigation. | Supported by large, randomized studies as the established first-line treatment for metastatic pancreatic cancer, including those with peritoneal spread. |
| Important risks | Potential for surgical complications (infection, bleeding, delayed recovery) and systemic or local toxicity from intraperitoneal chemotherapy. Major morbidity and perioperative mortality are reported in published studies. | Possible risks include neutropenia (low white blood cells), fatigue, infections, nausea, peripheral neuropathy, and increased bleeding tendency, depending on chosen regimen. |
| Important limitations | Limited to highly selected patients who respond to preoperative chemotherapy and have isolated peritoneal metastases. Broader benefit unknown. Evidence base remains preliminary; more data needed on long-term outcomes and ideal patient selection. | Disease may progress despite standard therapy, symptom control is sometimes incomplete, and long-term survival rates remain low for advanced disease. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 treatment sessions over an unspecified period
Participants undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with nab-paclitaxel and cisplatin over 90 minutes. Additional HIPEC treatments with paclitaxel and cisplatin may occur up to 5 times depending on disease progression and tolerance.
Up to 5 treatment visits (in-person)
Duration - Up to 4 years
After completing treatment, participants are followed up to monitor overall survival, disease progression, and morbidity outcomes.
Visits every 6 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Hallbera Gudmundsdottir, Jennifer A Yonkus, Cornelius A Thiels...
https://pubmed.ncbi.nlm.nih.gov/37596449/Mayo Clinic
Lead Sponsor
