Clinical trial · Interventional
Effect of Refnot on Immunity in Cancer Patients
NCT05898451CI-TRIAL-00067066R-2completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study was planned to include disseminated patients with various solid tumors (melanoma, soft tissue sarcoma, breast cancer, colon cancer, etc.). The study drug was administered subcutaneously at a dose of 400,000 IU once a day, 3 times a week (every other day), for 4 weeks. In the absence of disease progression - an additional 4 weeks.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) | Drug | — | UNRESOLVED |
| Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Independent use of Refnot
- description
- Refnot is administered at a dose of 400,000 IU subcutaneously 3 times a week for 4 weeks. 4 weeks constitute 1 course of treatment with Refnot. In the absence of progression of the disease - an additional 4 weeks.
- interventionNames
- Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T)
- type
- EXPERIMENTAL
- label
- The use of Refnot in combination with chemotherapy
- description
- Refnot is administered at a dose of 400,000 IU subcutaneously 3 times a week for 4 weeks. 4 weeks constitute 1 course of treatment with Refnot. In the absence of progression of the disease - an additional 4 weeks. Chemotherapy may be used after 4-8 weeks of Refnot use.
- interventionNames
- Drug: Tumor necrosis factor-thymosin alfa 1 recombinant (TNF-T) and chemotherapy
Primary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have exhausted standard methods of treatment. * Morphological (histological or cytological) confirmation of the diagnosis. * Age no more than 75 years. * General condition 0-2 (WHO). * Estimated life expectancy of at least 3 months. * Consent to treatment under this protocol. * The number of granulocytes is more than 2000/mm, platelets are more than 150000/mm. * The level of creatinine should not exceed 1.5 norms, liver enzymes (ALT, AST and alkaline phosphatase) should not exceed 3 norms. * For common disease, patients should receive standard treatment earlier. Exclusion Criteria: * Severe manifestations of cardiovascular diseases in the past and at present (myocardial infarction, hypertension, stroke, phlebothrombosis, coronary insufficiency requiring drug control, etc.). * Peptic ulcer of the stomach, duodenal ulcer (in the acute phase), uncorrected diabetes mellitus. * Mental illness preventing understanding of the treatment plan. * Pregnancy. * Metastases of a malignant tumor in the brain (according to clinical data). * Chronic use of corticosteroids or immunosuppressants. * Various neurological diseases that prevent this treatment. * Known allergic reactions and/or other significant allergic conditions. * Any immunotherapy within the last 6 weeks prior to enrollment in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.