Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer

NCT ID: NCT06249750

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed 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.

Conditions

Metastatic Castration-resistant Prostate Cancer (CRPC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Immunotherapy

Intervention Type: DRUG

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.

Targeted therapy

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Immunotherapy

Intervention Type: DRUG

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.

Targeted therapy

Intervention Type: DRUG

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.

Hyperthermia

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

Immune checkpoint inhibitor; ICI; Tislelizumab (BeiGene, China); RTK inhibitor; Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China); ET-SPACE whole body hyperthermia; near infrared irradiation; ET-SPACE™ (Shenzhen ET medical, China); heat stress

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pengyuan Liu

OTHER

Sponsor Role: lead

Responsible Party

Pengyuan Liu

Research Secretary

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhejiang Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pengyuan Liu

Role: CONTACT

oncologyliupengyuan@outlook.com

18368846455

Facility Contacts

Pengyuan Liu

Role: primary

oncologyliupengyuan@outlook.com

18368846455

Other Identifiers

HEAIS007

Identifier Type: -

Identifier Source: org_study_id