Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 4:51 AM
Study NCT ID:
NCT05737368
Status:
UNKNOWN
Last Update Posted:
2023-02-21
First Post:
2023-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': '3 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Local control rate (LC)', 'timeFrame': 'from date of enrollment to date of first documented local progression. Assessed up to 6 months', 'description': 'The proportion of patients without tumor progression on imaging of brain glioma lesions was evaluated by RANO standard.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months', 'description': 'The ORR is defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'from date of enrollment to the date of progress. Assessed up to 6 months', 'description': 'The DCR is defined as the proportion of subjects with complete response, partial response, or stable disease based on RECIST Version 1.1.'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': 'from date of enrollment to the date of first documented progression. Assessed up to 6 months', 'description': 'the probability of 6-month disease progression-free survival was evaluated by RANO standard after treatment.'}, {'measure': 'survival (OS) rate', 'timeFrame': 'from date of enrollment to the date of death from any cause. Assessed up to 6months', 'description': 'Probability of survival for 6 months after treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Recurrent Glioblastoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. . Written and signed informed consent.\n2. . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent.\n3. Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence.\n4. The maximum diameter of recurrent tumor is less than 6 cm.\n5. Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past.\n6. The interval from the last radiotherapy is more than 6 months.\n7. KPS (Karnofsky function status score)\\>60.\n\nExclusion Criteria:\n\n1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.\n2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.\n3. Multiple malignant gliomas.\n4. Subtentorial glioblastoma or Extracranial metastatic lesions.\n5. Active autoimmune diseases.\n6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).'}, 'identificationModule': {'nctId': 'NCT05737368', 'briefTitle': 'Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab', 'orgStudyIdInfo': {'id': '2022-0995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients will receive the treatment of fractionated radiotherapy and Cadonilimab', 'description': 'fractionated radiotherapy (500cGy \\*5F, 600cGy\\*5F, 350cGy\\*10F, according to the tumor volume); within 14 days after receiving radiotherapy, Cardunizumab (10mg/kg, Q3W, d1)', 'interventionNames': ['Radiation: fractionated radiotherapy', 'Drug: cadonilimab']}], 'interventions': [{'name': 'fractionated radiotherapy', 'type': 'RADIATION', 'description': 'fractionated radiotherapy (500cGy \\*5F, 600cGy\\*5F, 350cGy\\*10F, according to the tumor volume)', 'armGroupLabels': ['Patients will receive the treatment of fractionated radiotherapy and Cadonilimab']}, {'name': 'cadonilimab', 'type': 'DRUG', 'description': 'Cardunizumab (10mg/kg, Q3W, d1)', 'armGroupLabels': ['Patients will receive the treatment of fractionated radiotherapy and Cadonilimab']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Yu, MD', 'role': 'CONTACT', 'email': '11418282@zju.edu.cn', 'phone': '+8657187783521'}], 'overallOfficials': [{'name': 'Qichun Wei, MD/PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}