Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 2:53 AM
Study NCT ID:
NCT07153094
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061766', 'term': 'Proton Therapy'}], 'ancestors': [{'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2031-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short term efficacy evaluation', 'timeFrame': '90 days after the treatment completion', 'description': 'Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria'}, {'measure': 'Short term safety evaluation', 'timeFrame': '90 days after the treatment completion', 'description': 'Toxicity of grade 3, 4 and 5 according to CTCAE'}], 'secondaryOutcomes': [{'measure': 'Additional short term Safety evaluation', 'timeFrame': '90 days after the treatment completion', 'description': 'Toxicity of grade 1 and 2 according to CTCAE'}, {'measure': 'Long term Efficacy evaluation', 'timeFrame': '6 months, 1 year, 2 years and 5 years after the treatment completion', 'description': 'Disease Control Rate (DCR)'}, {'measure': 'Long term Safety evaluation', 'timeFrame': '6 months, 1 year, 2 years, and 5 years after the treatment completion', 'description': 'Toxicity of grade 1,2, 3, 4 and 5 according to CTCAE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Proton therapy'], 'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device.\n\nThe trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.', 'detailedDescription': 'The trial is structured in two distinct phases. Phase 1 - Clinical Trial: This phase spans from the initial screening through to 90 days post-treatment. Its primary objective is to assess the efficacy and safety of PROTEUS® PLUS in accordance with the regulatory requirements set by the National Medical Products Administration (NMPA) for product registration. Phase 2 - Long-Term Follow-Up: Extending up to five years after treatment, this phase aims to monitor the long-term efficacy and safety of PROTEUS® PLUS. Periodic reports will be submitted in compliance with NMPA guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (main):\n\n* Clinically diagnosed with benign/malignant intracranial tumor and malignant solid tumor of head and neck, chest, abdomen, spine, pelvic cavity and limbs\n* At least 1 lesion of the tumor to be treated is measurable according to RECIST criteria\n* Expected survival time of more than 6 months\n* ECOG performance status of 0 to 2\n* Negative pregnancy test (HCG) results within 7 days prior to the first treatment for females of childbearing potential\n\nExclusion Criteria (main):\n\n* Contraindications to radiation therapy\n* Presence of other uncontrolled tumors other than the tumor to be treated\n* Implants and devices in the treatment area\n* Re-irradiation\n* Other conditions that are not suitable for inclusion, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT07153094', 'briefTitle': 'Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ion Beam Applications'}, 'officialTitle': 'Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)', 'orgStudyIdInfo': {'id': 'IBA-03-SZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'Subjects will undergo radiation therapy using the investigational medical device (PROTEUS® PLUS) in accordance with the prescribed treatment plan.', 'interventionNames': ['Device: Proton Beam Therapy (PBT)']}], 'interventions': [{'name': 'Proton Beam Therapy (PBT)', 'type': 'DEVICE', 'description': 'PROTEUS® PLUS', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shenzhen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Jin, MD', 'role': 'CONTACT'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Sophie Le Bail, Msc', 'role': 'CONTACT', 'email': 'sophie.lebail@iba-group.com', 'phone': '+32470226032'}, {'name': 'Sofie Gillis, PhD', 'role': 'CONTACT', 'email': 'sofie.gillis@iba-group.com'}], 'overallOfficials': [{'name': 'Jing Jin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ion Beam Applications', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}