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Follistatin 344

FS-344, Activin-Binding Protein, FST344

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Studies 2
Trials 73
Unknown OBSERVATIONAL NCT02739048

Changes of Immunologic Function in Patients of Prostate Cancer Induced After Cryoablation.

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

1\. The overall objective of the study: By evaluating the curative effect of CSAP in localized prostate cancer, locally advanced prostate cancer and metastasis advanced prostate cancer, and the change of state in cellular immunity and humoral immunity before and after CSAP. Validate the clinical therapeutic effect of all kinds of prostate cancer, as well as the change of immune status before and after CSAP. 2\. The main content of the study: 1. Included in the samples are patients in hospitals for CSAP. The sample capacity are planned to be 80. The main purpose of the study is to observe the overall survival rate , disease free survival rate, the progress time of the PSA biochemical recurrence as well as the disease progress time. 2. Measure the change of concentration in peripheral blood T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells) and regulatory T cells before and after cryoablation within 1 month, 3 months and 6 months. 3. Measure the change of concentration in peripheral blood IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio), and detect the secretion of CD4 + Th tumor-specific IFN-l and the activity of tumor-specific killer CD8 + CTL before and after cryoablation within 2 weeks and 1 month. 4. Before cryoablation, detect the expression and distribution of Follistatin-Like1 (FSTL-1), Besides, verify the connection between the number and activation ratio of tumor local dendritic cells (DC) and the FSTL-1, evaluating the cryoablation effect on the immune response.

Primary Outcomes

Measure: humoral immunity and cellular immunity will be activated after CSAP for patients of prostate cancer
TimeFrame: 3 years
Description: All 80 participants' peripheral blood will be collected before CSAP and after CSAP to detect the concentration of T lymphocyte subsets (CD3 + T, CD4 + T, CD8 + T, CD4 + / CD8 + T, NK cells), IFN-1, IL-4, IFN-1/IL-4 ratio (Thl/Th2 ratio) and FSTL-1, and to comment the change of activity of humoral immunity and cellular immunity.

Trial Information

NCT ID

NCT02739048

Status

Unknown

Study Type

OBSERVATIONAL

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Last Updated

December 15, 2025

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