Clinical trial · Interventional
Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis
NCT04858009CI-TRIAL-00099009recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm in the Peritoneum | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer AJCC v8 | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Hyperthermic Intraperitoneal Chemotherapy | Drug | Hyperthermic Intraperitoneal Chemotherapy | ALIAS |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (HIPEC)
- description
- Patients undergo HIPEC with nab-paclitaxel and cisplatin over 90 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times. Patients undergo CT scan, MRI or PET during screening.
- interventionNames
- Drug: Cisplatin
- Drug: Hyperthermic Intraperitoneal Chemotherapy
- Drug: Nab-paclitaxel
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Up to 4 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGudmundsdottir H, Yonkus JA, Thiels CA, Warner SG, Cleary SP, Kendrick ML, Truty MJ, Grotz TE. Oncologic Outcomes of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Highly Selected Patients with Metastatic Pancreatic Ductal Adenocarcinoma. Ann Surg Oncol. 2023 Nov;30(12):7833-7839. doi: 10.1245/s10434-023-14138-3. Epub 2023 Aug 19. PMID 37596449