Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID04858009

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis

Led by Mayo Clinic · Updated on 2025-12-16

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief 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 confirmation of pancreatic adenocarcinoma
  • Leukocytes count of at least 3,000/uL
  • Absolute neutrophil count of at least 1,500/uL
  • Platelets count of at least 60,000/Ul
  • Serum creatinine level of 1.5 mg/dL or lower
  • Presence of limited peritoneal metastatic disease confirmed by imaging or cytology
  • Completion of preoperative systemic chemotherapy with significant biochemical, metabolic, or radiographic response
  • Peritoneal Carcinomatosis Index (PCI) of 7 or less with high likelihood of complete cytoreduction as judged by surgeon
Not Eligible

You will not qualify if you...

  • Metastatic disease beyond the peritoneum, including liver, central nervous system, or lung involvement
  • Active infections such as pneumonia or wound infections preventing protocol therapy
  • Positive pregnancy test or women of childbearing potential not agreeing to adequate contraception
  • Inability to comply with study or follow-up procedures
  • Known life-threatening hypersensitivity to systemic chemotherapy used in the protocol or related severe reactions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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

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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Published Research Related To This Trial

Oncologic Outcomes of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Highly Selected Patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Hallbera Gudmundsdottir, Jennifer A Yonkus, Cornelius A Thiels...

https://pubmed.ncbi.nlm.nih.gov/37596449