Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.