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

NCT06249750 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: HEAIS007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Castration-resistant Prostate Cancer (CRPC)

Keywords

hyperthermia, immune checkpoint inhibitor, RTK inhibitor, CRPC

Outcome Measures

Primary Outcomes (1)

• Biochemical objective response rate (BORR)

  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%.

  3 weeks

Secondary Outcomes (1)

• Bio-Disease Control Rate （BDCR）

  3 weeks

Study Arms (2)

Immuno-targeted therapy group

EXPERIMENTAL

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.

Drug: Immunotherapy; Drug: Targeted therapy

Hyperthermia-immuno-targeted therapy group

EXPERIMENTAL

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.

Drug: Immunotherapy; Drug: Targeted therapy; Device: Hyperthermia

Interventions

Immunotherapy 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.

Also known as: Immune checkpoint inhibitor, ICI, Tislelizumab (BeiGene, China)

Hyperthermia-immuno-targeted therapy group; Immuno-targeted therapy group

Targeted therapy 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.

Also known as: RTK inhibitor, Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)

Hyperthermia-immuno-targeted therapy group; Immuno-targeted therapy group

Hyperthermia 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.

Also known as: ET-SPACE whole body hyperthermia, near infrared irradiation, ET-SPACE™ (Shenzhen ET medical, China), heat stress

Hyperthermia-immuno-targeted therapy group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pengyuan Liu: lead

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

RECRUITING

MeSH Terms

Conditions

Hyperthermia

Interventions

Immunotherapy; Immune Checkpoint Inhibitors; tislelizumab; anlotinib; Diathermy

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Hyperthermia, Induced

Central Study Contacts

Pengyuan Liu

CONTACT

18368846455; oncologyliupengyuan@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Secretary

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)