Clinical trial · Interventional
Hyperthermia/Thermal Therapy With Chemotherapy to Treat Inoperable or Metastatic Tumors
A Phase II Clinical Trial of Cisplatin + Gemcitabine HCl (GEM) + Low-Dose Metronomic Interferon-a (IFN-a) Combined With Fever-Range Whole-Body Thermal Therapy (FR-WB-TT) in Patients With Metastatic/or Locally Advanced Malignancies (Small-Cell Lung Cancer, Neuroendocrine Cancer, Gastric 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) increases chemotherapy cancer cell kill. By itself, thermal therapy can also kill cancer cells. Whole body thermal therapy is a systemic treatment; whole-body fever-range thermal therapy can safely treat cancer cells wherever they are throughout the entire body. In this study, we are testing the combination of fever-range heat treatment and chemotherapy to test 1) The response of three types of cancer (small-cell lung, neuroendocrine cancer, lung cancer, and gastric cancer) to the thermo-chemotherapy improves cancer response compared to the effect of only chemotherapy drugs in current use; 2) whether the thermo-chemotherapy treatment helps the person's own body fight the cancer cells; and 3) whether this treatment is safe and comfortable for the patient. This study does not offer heat treatment alone. Any patient with inoperable or metastatic small cell lung cancer, neuroendocrine cancer (any organ), gastric cancer, or lung cancer, can be treated with the Phase II protocol therapy; however, the patient will need to undergo selected medical tests to make sure this treatment would be safe for them.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Neuroendocrine Cancer | Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin, Gemcitabine, Interferon-a | Drug | — | UNRESOLVED |
| thermochemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- Thermochemotherapy
- interventionNames
- Other: thermochemotherapy
- Drug: Cisplatin, Gemcitabine, Interferon-a
Primary outcomes (3)
- measure
- Tumor Response by RECIST criteria (CR+PR)
- timeFrame
- 5 years
- measure
- Response Duration
- timeFrame
- 5 years
- measure
- Survival
- timeFrame
- 5 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Any patient with inoperable or metastatic small-cell lung cancer, neuroendocrine cancer (any organ), gastric cancer, of lung cancer are eligible for protocol treatment. However the patient: * Must not have metastasis to the brain * Must be able to achieve positive results on preliminary tests * Must have a good ECOG performance status Exclusion Criteria: * Metastasis to the brain * Poor results on preliminary physiological tests * a Poor ECOG performance status score
References
Publications (0)
Data not yet available