Clinical trial · Interventional
Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer
Phase II Clinical Trial of Cisplatin + Gemcitabine in Combination With Mild, Fever-Range Whole-Body Hyperthermia to Treat Patients With Advanced, Inoperable Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment that includes the entire body. By using fever-range whole-body thermal therapy, cancer cells can be treated wherever they are throughout the entire body. In this study, we are testing a combination of fever-range thermal therapy combined with chemotherapy to test: 1) the response of metastatic or advanced pancreas cancer to the combined modality treatment of thermotherapy and selected chemotherapy; 2) whether it helps the body immunity fight the pancreas cancer; and 3) if this treatment is safe for the patient. This study does not offer thermal therapy alone. Any patient with measurable, inoperable or metastatic pancreatic cancer may be treated; however, the they will need to undergo specific medical tests to make sure this treatment would be safe for them. We hypothesize that a combined-modality therapy using fever-range whole-body hyperthermia (FR-WBH; temperature = 40 o C; duration = 6 h), administered in an optimized time/sequence schedule with cisplatin, gemcitabine HCl (gemcitabine), and metronomically administered, low-dose interferon-alpha (IFN-alpha) to patients with inoperable or metastatic pancreas cancer, will, without inducing intolerable toxicity: a.) decrease the pancreatic cancer size; b.) improve quality of life; c.) enhance the immune response against the cancer; d.) increase survival; and e.) allow inoperable pancreatic cancer to be converted to operable disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin, gemcitabine, interferon-alpha | Other | — | UNRESOLVED |
| Heckel Infrared Radiant Heat Device | Device | — | UNRESOLVED |
| thermochemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- All protocol subjects are treated with fever-range whole-body thermal therapy combined in an optimized schedule with cisplatin + gemcitabine + metronomic low-dose interferon-alpha
- interventionNames
- Device: Heckel Infrared Radiant Heat Device
- Other: cisplatin, gemcitabine, interferon-alpha
- Other: thermochemotherapy
Primary outcomes (1)
- measure
- Tumor response, disease-free survival
- timeFrame
- 2 months to 5 years
Secondary outcomes (1)
- measure
- Allow inoperable pancreatic cancer to be converted to operable disease
- timeFrame
- 2 months to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Candidate must have biopsy-documented locally advanced or metastatic pancreas cancer * Must be able to successfully complete preliminary function tests * Must have a good ECOG score * Must have two functioning lungs Exclusion Criteria: * Must not have active metastasis to the brain * Must not have poor preliminary function tests * Must not have a low ECOG score * Must not be taking high-dose corticosteroids * Must be psychologically stable
References
Publications (0)
Data not yet available