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NCT Number: NCT06249750

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

Location status: Recruiting

Location contact

Pengyuan Liu

CONTACT

[email protected]

18368846455

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Immune checkpoint inhibitor, ICI, Tislelizumab (BeiGene, China)

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.

Other names: RTK inhibitor, Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)

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.

Other names: ET-SPACE whole body hyperthermia, near infrared irradiation, ET-SPACE™ (Shenzhen ET medical, China), heat stress

Primary outcomes

  1. Biochemical objective response rate (BORR)

    Time frame: 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%.

Secondary outcomes

  1. Bio-Disease Control Rate (BDCR)

    Time frame: 3 weeks

    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.

    Bio Progression Disease (BPD): PSA increased by ≥ 25% from baseline. BDCR=BCR+BPR+BPD/All patients × 100%.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengyuan Liu

CONTACT

[email protected]

18368846455

Sponsors and collaborators

Lead sponsor

Pengyuan Liu

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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