Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biochemical objective response rate (BORR)
研究概览
简要总结
In this study, we propose to use the combination of ET-SPACE NIR irradiation whole-body thermal stimulation, ICI (Tislelizumab), and RTK inhibitor (Anlotinib) in the multimodal treatment of CRPC.
详细描述
The initial efficacy and safety of the multimodal therapy will be evaluated at the animal level to fully validate the potential feasibility of the therapy. Subsequently, the efficacy of the multimodal therapy will be verified at the organoid level, and based on which a translational randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the multimodal therapy at the human level, and the patients will be followed up for a long period of time, so as to collect detailed data on improvement of the quality of life. Finally, the synergistic effect of the multimodal therapy will be analyzed at the molecular and cellular levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed diagnosis of PC and clinically confirmed diagnosis of CRPC;
- •Complete and reliable medical history and medical records;
- •No other primary tumors except CRPC;
- •Blood tests, liver function, renal function and electrocardiogram are basically normal;
- •Patients with ECOG score 0~3, aged ≥18 years and <90 years old;
- •Patients with good compliance, able to accept regular follow-up.
排除标准
- •History of malignant tumor other than PC within the past 5 years;
- •Severe abnormalities in the patient's laboratory indices may jeopardize patient safety or compromise this study;
- •Accompanied by severe underlying diseases that cannot tolerate this therapy;
- •With acute diseases, such as acute infection, active bleeding;
- •Those who have recently participated in other clinical trials and have not passed the washout period;
- •Those who cannot tolerate systemic heat stress, such as claustrophobic patients;
- •Those who have a history of allergy to the drugs used in the trial;
- •Patients with other reasons for not being able to be enrolled in the study, according to the study doctor.
研究组 & 干预措施
Immuno-targeted therapy group
ICI regimen: Tislelizumab, 200mg, ivgtt., d1, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d1~14, q21d.
干预措施: Immunotherapy (Drug)
Immuno-targeted therapy group
ICI regimen: Tislelizumab, 200mg, ivgtt., d1, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d1~14, q21d.
干预措施: Targeted therapy (Drug)
Hyperthermia-immuno-targeted therapy group
ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5~39 ℃ and then maintain 1h. ICI regimen: Tislelizumab, 200mg, ivgtt., d2, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d2~15, q21d.
干预措施: Immunotherapy (Drug)
Hyperthermia-immuno-targeted therapy group
ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5~39 ℃ and then maintain 1h. ICI regimen: Tislelizumab, 200mg, ivgtt., d2, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d2~15, q21d.
干预措施: Targeted therapy (Drug)
Hyperthermia-immuno-targeted therapy group
ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5~39 ℃ and then maintain 1h. ICI regimen: Tislelizumab, 200mg, ivgtt., d2, q21d; RTK inhibitor regimen: Anlotinib, 12mg (at an initial dose of 12mg, later adjusted according to the instructions), po., d2~15, q21d.
干预措施: Hyperthermia (Device)
结局指标
主要结局
Biochemical objective response rate (BORR)
时间窗: 3 weeks
Detect blood PSA levels before and during treatment, compare baseline and post treatment PSA difference levels, and evaluate efficacy. Bio Complete Response (BCR): PSA remains normal or decreases to normal (4ng/mL) for at least 3 weeks. Partial Biochemical Response (BPR): PSA decreased by ≥ 50% from baseline and maintained for at least 3 weeks. BPRR=BCR+BPR/All patients × 100%.
次要结局
- Bio-Disease Control Rate （BDCR）(3 weeks)
研究者
Pengyuan Liu
Research Secretary
Zhejiang Hospital