Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-30 @ 9:49 AM
Study NCT ID:
NCT06943235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-24
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one year progression free survival rate', 'timeFrame': 'one year'}, {'measure': 'Complete response rate at the end of radiotherapy for one month', 'timeFrame': 'at the end of radiotherapy for one month'}], 'secondaryOutcomes': [{'measure': 'One year overall survival rate', 'timeFrame': 'one year'}, {'measure': 'one year Survival rate without distant metastasis', 'timeFrame': 'one year'}, {'measure': 'Adverse reactions', 'timeFrame': 'one year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Limited Stage Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'ADRIATIC study explored the benefits of immune maintenance therapy after LS-SCLC radiotherapy and chemotherapy. In the presence of immunotherapy, is it necessary to increase the dosage of radiotherapy and can it further improve the efficacy? This study aims to explore the efficacy and safety of simultaneous integrated boost hyperfractionation radiotherapy combined with probiotics and Adalberg monoclonal antibody consolidation therapy for small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sign written informed consent before implementing any experimental procedures;\n2. Age range: 18-80 years old;\n3. Pathological diagnosis of small cell lung cancer;\n4. Limited stage;\n5. ECOG PS 0-1；\n6. Receive ≤ 2 rounds of chemotherapy or chemotherapy plus immunotherapy;\n7. Expected survival time\\>3 months;\n\nExclusion Criteria:\n\n1. Progress after 2 induction treatments;\n2. Severe emphysema, interstitial changes in the lungs, COPD patients;\n3. Resting blood oxygen\\<93;\n4. Have a history of other malignant tumors and have received chemotherapy in the past 3 years;\n5. History of chest radiotherapy;'}, 'identificationModule': {'nctId': 'NCT06943235', 'briefTitle': 'Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Controlled, Phase II Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)', 'orgStudyIdInfo': {'id': '2503317-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance', 'description': 'Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.', 'interventionNames': ['Drug: Probiotics', 'Radiation: concurrent Hyperfractionated Radiotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance', 'description': 'Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.', 'interventionNames': ['Radiation: concurrent Hyperfractionated Radiotherapy']}], 'interventions': [{'name': 'Probiotics', 'type': 'DRUG', 'description': 'Subjects received probiotics before radiotherapy', 'armGroupLabels': ['Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance']}, {'name': 'concurrent Hyperfractionated Radiotherapy', 'type': 'RADIATION', 'description': 'Increase radiation dose on the basis of conventional radiotherapy', 'armGroupLabels': ['Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance', 'Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xingwen Fan', 'role': 'CONTACT', 'email': 'wenxingfan@126.com', 'phone': '+86 13651669687'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Xingwen Fan', 'investigatorAffiliation': 'Fudan University'}}}}