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

January 31, 2024 updated by: Pengyuan Liu
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Immune checkpoint inhibitor
  • ICI
  • Tislelizumab (BeiGene, China)
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.
Other Names:
  • RTK inhibitor
  • Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)
Experimental: 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.
Drug: 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.
Other Names:
  • Immune checkpoint inhibitor
  • ICI
  • Tislelizumab (BeiGene, China)
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.
Other Names:
  • RTK inhibitor
  • Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)
Device: 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.
Other Names:
  • ET-SPACE whole body hyperthermia
  • near infrared irradiation
  • ET-SPACE™ (Shenzhen ET medical, China)
  • heat stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pengyuan Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEAIS007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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