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This open-label, single-arm study evaluates the safety and preliminary efficacy of LC-K76 combined with Tislelizumab and ADT in 10 patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who progressed on prior therapies. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LC-K76 + Tislelizumab + ADT | Experimental | Participants receive oral LC-K76 combined with intravenous Anti-PD-1 monoclonal antibody (Tislelizumab) and standard androgen deprivation therapy (ADT). Treatment continues for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC-K76 | Dietary Supplement | Oral administration, 1.2 g twice daily (BID), taken 30 minutes before breakfast and dinner. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | The Incidence of Adverse Events is defined as the proportion of subjects in a clinical trial who experience at least one Adverse Event (AE) during the defined observation period, which is assessed by CTCAE 5.0. | From baseline to primary completion, which may take up to 24 to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PSA Response Rate | From baseline to primary completion, which may take up to 24 to 48 weeks | |
| Disease control rate (DCR) | Defined as the proportion of subjects whose best overall response, assessed per RECIST 1.1 and PCWG3, is Complete Response (CR), Partial Response (PR), or Stable Disease (SD) . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren, MD,PhD | Contact | 86021-81886999 | renshancheng@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changzheng hospital | Shanghai | Shanghai Municipality | 201109 | China |
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| Tislelizumab | Drug | Intravenous infusion, 200 mg every 3 weeks (Q3W). |
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| Standard Androgen Deprivation Therapy (ADT) | Drug | Maintenance of ADT using GnRH agonist or antagonist (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix). |
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| From baseline to primary completion, which may take up to 24 to 48 weeks |
| Radiographic Progression-Free Survival (rPFS) | Defined as the time from treatment initiation to the first objective evidence of disease progression as assessed by radiographic imaging, or death from any cause, whichever occurs first. | From baseline to primary completion, which may take up to 24 to 48 weeks |
| Time to First Skeletal-Related Event (SRE) | Defined as the interval from the date of treatment initiation to the date of the first occurrence of any of the following clinically significant events attributable to bone metastasis: pathological fracture (vertebral or non-vertebral), palliative radiation therapy to bone for pain relief, surgical intervention to bone to prevent or treat a fracture or spinal cord compression, or confirmed spinal cord compression. | From baseline to primary completion, which may take up to 24 to 48 weeks |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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