Metastatic Castration-resistant Prostate Cancer (CRPC)Phase 2NCT06249750
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
A Phase 2 study testing Immunotherapy, Targeted therapy and Hyperthermia in people with Metastatic Castration-resistant Prostate Cancer (CRPC), run by Pengyuan Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (CRPC)
- What is being tested?
- Immunotherapy, Targeted therapy and Hyperthermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310013
Pengyuan Liu, 18368846455, oncologyliupengyuan@outlook.com
About this study
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.
Read the 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.
- Being tested
- Immunotherapy, Targeted therapy, Hyperthermia
- Keywords
- hyperthermia, immune checkpoint inhibitor, RTK inhibitor, CRPC
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Also called Immune checkpoint inhibitor, ICI, Tislelizumab (BeiGene, China)
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 therapyDrug
Also called RTK inhibitor, Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)
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.
HyperthermiaDevice
Also called ET-SPACE whole body hyperthermia, near infrared irradiation, ET-SPACE™ (Shenzhen ET medical, China), heat stress
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Immunotherapy; Drug: Targeted therapy; Device: Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 3 weeks
Secondary outcomes (1)
Bio-Disease Control Rate （BDCR）
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%.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (CRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pengyuan Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pengyuan Liu, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249750
- Sponsor's protocol ID
- HEAIS007
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No