To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
NCT ID:
NCT06249750
Condition:
Metastatic Castration-resistant Prostate Cancer (CRPC)
Conditions: Official terms:
Prostatic Neoplasms
Tislelizumab
Immune Checkpoint Inhibitors
Conditions: Keywords:
hyperthermia, immune checkpoint inhibitor, RTK inhibitor, CRPC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Immunotherapy
Description:
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.
Arm group label:
Hyperthermia-immuno-targeted therapy group
Arm group label:
Immuno-targeted therapy group
Other name:
Immune checkpoint inhibitor
Other name:
ICI
Other name:
Tislelizumab (BeiGene, China)
Intervention type:
Drug
Intervention name:
Targeted therapy
Description:
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.
Arm group label:
Hyperthermia-immuno-targeted therapy group
Arm group label:
Immuno-targeted therapy group
Other name:
RTK inhibitor
Other name:
Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)
Intervention type:
Device
Intervention name:
Hyperthermia
Description:
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.
Arm group label:
Hyperthermia-immuno-targeted therapy group
Other name:
ET-SPACE whole body hyperthermia
Other name:
near infrared irradiation
Other name:
ET-SPACE™ (Shenzhen ET medical, China)
Other name:
heat stress
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Hospital
Address:
City:
Hangzhou
Zip:
310013
Country:
China
Status:
Recruiting
Contact:
Last name:
Pengyuan Liu
Phone:
18368846455
Email:
oncologyliupengyuan@outlook.com
Start date:
January 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Pengyuan Liu
Agency class:
Other
Source:
Zhejiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06249750
