An Open-Label, Single-Arm, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, aged 18 to 85 years.
- •Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components.
- •Metastatic Castration-Resistant Prostate Cancer (mCRPC) with disease progression after at least one novel endocrine therapy (e.g., abiraterone or enzalutamide) and/or docetaxel chemotherapy.
- •Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT).
- •Serum testosterone at castration levels (< 50 ng/dL or 1.75 nmol/L).
- •ECOG performance status ≤
- •Life expectancy > 6 months.
- •Adequate bone marrow, hepatic, and renal function.
- •Willing to undergo biopsies before and during treatment
排除标准
- •Lack of pathological evidence for prostate cancer.
- •Other primary malignant tumors active or requiring treatment within the past 3 years.
- •Has visceral metastases.
- •Poorly controlled diabetes after continuous insulin therapy.
- •Significant abnormalities in laboratory values at randomization (Hb < 90 g/L; Neutrophils < 1.5x10^9/L; Platelets < 75x10^9/L; ALT/AST > 2.5xULN; Bilirubin > 1.5xULN; eGFR < 60 mL/min/1.73m^2) .
- •Severe cardiopulmonary disease or high-risk conditions.
- •Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1).
- •Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts.
- •History of severe drug allergies.
- •Factors affecting drug intake/absorption (e.g., swallowing difficulty, chronic diarrhea).
- •Concurrent psychiatric or neurological conditions
研究组 & 干预措施
LC-K76 + Tislelizumab + ADT
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.
干预措施: LC-K76 (Dietary Supplement)
LC-K76 + Tislelizumab + ADT
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.
干预措施: Tislelizumab (Drug)
LC-K76 + Tislelizumab + ADT
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.
干预措施: Standard Androgen Deprivation Therapy (ADT) (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: From baseline to primary completion, which may take up to 24 to 48 weeks
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.
次要结局
- PSA Response Rate(From baseline to primary completion, which may take up to 24 to 48 weeks)
- Disease control rate (DCR)(From baseline to primary completion, which may take up to 24 to 48 weeks)
- Radiographic Progression-Free Survival (rPFS)(From baseline to primary completion, which may take up to 24 to 48 weeks)
- Time to First Skeletal-Related Event (SRE)(From baseline to primary completion, which may take up to 24 to 48 weeks)
研究者
Ren Shancheng
Professor, Chief of Urology
Shanghai Changzheng Hospital