Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 2:30 AM
Study NCT ID:
NCT06249750
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C000625192', 'term': 'anlotinib'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical objective response rate (BORR)', 'timeFrame': '3 weeks', 'description': 'Detect blood PSA levels before and during treatment, compare baseline and post treatment PSA difference levels, and evaluate efficacy.\n\nBio Complete Response (BCR): PSA remains normal or decreases to normal (4ng/mL) for at least 3 weeks.\n\nPartial Biochemical Response (BPR): PSA decreased by ≥ 50% from baseline and maintained for at least 3 weeks.\n\nBPRR=BCR+BPR/All patients × 100%.'}], 'secondaryOutcomes': [{'measure': 'Bio-Disease Control Rate （BDCR）', 'timeFrame': '3 weeks', 'description': 'Bio Complete Response (BCR): PSA remains normal or decreases to normal (4ng/mL) for at least 3 weeks.\n\nPartial Biochemical Response (BPR): PSA decreased by ≥ 50% from baseline and maintained for at least 3 weeks.\n\nBio Progression Disease (BPD): PSA increased by ≥ 25% from baseline. BDCR=BCR+BPR+BPD/All patients × 100%.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hyperthermia, immune checkpoint inhibitor, RTK inhibitor, CRPC'], 'conditions': ['Metastatic Castration-resistant Prostate Cancer (CRPC)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histopathologically confirmed diagnosis of PC and clinically confirmed diagnosis of CRPC;\n* Complete and reliable medical history and medical records;\n* No other primary tumors except CRPC;\n* Blood tests, liver function, renal function and electrocardiogram are basically normal;\n* Patients with ECOG score 0\\~3, aged ≥18 years and \\<90 years old;\n* Patients with good compliance, able to accept regular follow-up.\n\nExclusion Criteria:\n\n* History of malignant tumor other than PC within the past 5 years;\n* Severe abnormalities in the patient's laboratory indices may jeopardize patient safety or compromise this study;\n* Accompanied by severe underlying diseases that cannot tolerate this therapy;\n* With acute diseases, such as acute infection, active bleeding;\n* Those who have recently participated in other clinical trials and have not passed the washout period;\n* Those who cannot tolerate systemic heat stress, such as claustrophobic patients;\n* Those who have a history of allergy to the drugs used in the trial;\n* Patients with other reasons for not being able to be enrolled in the study, according to the study doctor."}, 'identificationModule': {'nctId': 'NCT06249750', 'briefTitle': 'Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Hospital'}, 'officialTitle': 'Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'HEAIS007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immuno-targeted therapy group', 'description': '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.', 'interventionNames': ['Drug: Immunotherapy', 'Drug: Targeted therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Hyperthermia-immuno-targeted therapy group', 'description': '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.', 'interventionNames': ['Drug: Immunotherapy', 'Drug: Targeted therapy', 'Device: Hyperthermia']}], 'interventions': [{'name': 'Immunotherapy', 'type': 'DRUG', 'otherNames': ['Immune checkpoint inhibitor', 'ICI', 'Tislelizumab (BeiGene, China)'], '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.', 'armGroupLabels': ['Hyperthermia-immuno-targeted therapy group', 'Immuno-targeted therapy group']}, {'name': 'Targeted therapy', 'type': 'DRUG', 'otherNames': ['RTK inhibitor', 'Anlotinib (CHIATAI TIANQING PHARMACEUTICAL GROUP, China)'], '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.', 'armGroupLabels': ['Hyperthermia-immuno-targeted therapy group', 'Immuno-targeted therapy group']}, {'name': 'Hyperthermia', 'type': 'DEVICE', 'otherNames': ['ET-SPACE whole body hyperthermia', 'near infrared irradiation', 'ET-SPACE™ (Shenzhen ET medical, China)', 'heat stress'], '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.', 'armGroupLabels': ['Hyperthermia-immuno-targeted therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310013', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengyuan Liu', 'role': 'CONTACT', 'email': 'oncologyliupengyuan@outlook.com', 'phone': '18368846455'}], 'facility': 'Zhejiang Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Pengyuan Liu', 'role': 'CONTACT', 'email': 'oncologyliupengyuan@outlook.com', 'phone': '18368846455'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pengyuan Liu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Secretary', 'investigatorFullName': 'Pengyuan Liu', 'investigatorAffiliation': 'Zhejiang Hospital'}}}}