Clinical trial
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
Name
HEAIS007
Description
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.
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Immunotherapy
Immunotherapy is currently a hot spot in the field of tumor research. Immune Checkpoint Inhibitor (ICI) is a monoclonal antibody designed to target the negative immunoregulatory pathway overexpressed in tumor cells, which can release the anti-tumor immunosuppressive signals and restore the killing of tumors by the immune cells, and thus exert anti-tumor effects. ICI regimen: Tislelizumab, 200mg, ivgtt., d1, q21d.
Arms:
Hyperthermia-immuno-targeted therapy group, Immuno-targeted therapy group
Other names:
Immune checkpoint inhibitor, ICI, Tislelizumab (BeiGene, China)
Targeted therapy
Recent studies have found that the combination of RTK inhibitors and ICIs can exert synergistic effects on different mechanisms, which can compensate for the deficiencies of single-agent RTK inhibitors and single-agent ICIs in the treatment of CRPC and become a potential novel therapeutic strategy for solid malignant tumors. RTK inhibitor regimen: Anlotinib, 12mg, po., d2\~15, q21d.
Arms:
Hyperthermia-immuno-targeted therapy group, Immuno-targeted therapy group
Other names:
RTK inhibitor, Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)
Hyperthermia
Thermal stimulation is a rapidly developing physiotherapeutic tool, which is playing an increasingly important role in the field of comprehensive tumor therapy due to its unique low adverse effects and high compatibility. A large number of clinical studies have shown that the addition of heat stress to multimodal tumor therapy does not significantly increase toxicity and side effects, and the combination of heat stress with other therapies can have the effect of "1+1\>2". ET-SPACE near-infrared irradiation whole-body hyperthermia: d1, d8, q21d, rectal temperature reaches 38.5\~39 ℃ and then maintain 1h.
Arms:
Hyperthermia-immuno-targeted therapy group
Other names:
ET-SPACE whole body hyperthermia, near infrared irradiation, ET-SPACE™ (Shenzhen ET medical, China), heat stress
Size
60
Primary endpoint
Biochemical objective response rate (BORR)
3 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-02-08
1 organization
Organization
Pengyuan Liu