Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-29 @ 7:52 PM
Study NCT ID:
NCT06188650
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '1 year', 'description': 'objective response rate'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '2 years', 'description': 'Progression Free Survival'}, {'measure': 'OS', 'timeFrame': '3 years', 'description': 'Overall Survival'}, {'measure': 'DCR', 'timeFrame': '3 years', 'description': 'Disease Control Rate'}, {'measure': 'DoR', 'timeFrame': '3 years', 'description': 'Duration of Overall Response'}, {'measure': 'AE', 'timeFrame': '3 years', 'description': 'adverse event'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about Drug loaded microspheres for bronchial artery chemoembolization (DEB-BACE) combined with anlotinib and adebelimumab in patients with advanced NSCLC after second-line treatment.\n\nThe main question it aims to answer is:\n\nThe efficacy and safety of Drug Loading Beads Bronchial Arterial Chemoembolization (DEB-BACE) combined with Anlotinib and Adebelimumab in the third line treatment of advanced NSCLC.\n\nParticipants will receive DEB-BACE treatment, rest for 1 week and then undergo 1 cycle of treatment with combination of Anlotinib and Adebelimumab. With a maximum of 4 DEB-BACE treatments depending on the therapeutic effect, followed by continued treatment with Anlotinib and Adebelimumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\\>18 years old, gender unlimited;\n2. According to the Diagnosis and Treatment Guidelines for Primary Lung Cancer (2018 Edition), NSCLC was diagnosed by pathological histology;\n3. TNM staging is III - IV;\n4. Failure of second-line treatment according to the CSCO guidelines;\n5. ECOG PS score ≤ 2 points;\n6. Estimated survival time\\>3 months;\n7. Sign informed consent form\n\nExclusion Criteria:\n\n1. Individuals who have previously received interventional therapy (iodine particle implantation, ablation, BACE treatment), or have received PD-L1 inhibitor immunotherapy during the first or second line standard treatment period of the patient;\n2. Patients with other malignant tumors that have not been cured;\n3. White blood cells\\<3 × 109/L, absolute value of neutrophils\\<1.5 × 109/L, neutrophil/lymphocyte ratio ≥ 3, platelet count\\<50 × 109/L, hemoglobin concentration\\<90 g/L;\n4. Liver and kidney dysfunction (creatinine\\>176.8) μ Mol/L; Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\\>twice the normal upper limit;\n5. Central squamous cell carcinoma with cavity features;\n6. Incorrectable coagulation dysfunction or concomitant active massive hemoptysis;\n7. Patients with concurrent active infections who require antibiotic treatment;\n8. Uncontrollable hypertension, diabetes, and cardiovascular diseases with obvious symptoms;\n9. Contrast agent allergy;\n10. Women with concurrent pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT06188650', 'briefTitle': 'The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ningbo Medical Center Lihuili Hospital'}, 'officialTitle': 'The Efficacy and Safety of Drug Loaded Microsphere Bronchial Artery Chemoembolization (DEB-BACE) Combined With Anlotinib and Adebelimumab in the Third Line Treatment of Advanced NSCLC: a Prospective, Single Arm, Single Center, Exploratory Clinical Study', 'orgStudyIdInfo': {'id': 'KY2023PJ261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Drug: Anlotinib']}], 'interventions': [{'name': 'Anlotinib', 'type': 'DRUG', 'otherNames': ['Adebrelimab', 'Drug-eluting Beads Bronchial Arterial Chemoembolization，DEB-BACE'], 'description': 'After receiving DEB-BACE treatment, the enrolled patients will rest for one week and then undergo one cycle of treatment with the combination of Anlotinib and Adebelimumab. After one course of treatment, the efficacy will be re evaluated, such as CR, and the treatment with Anlotinib and Adebelimumab will continue; For PR, SD, or PD, continue to receive DEB-BACE combined with anlotinib and adebelimumab as needed, with a maximum of 4 DEB-BACE treatments, followed by continued treatment with anlotinib and adebelimumab', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315040', 'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jingtao tong, master', 'role': 'CONTACT', 'email': 'vanssi@163.com', 'phone': '+8615088440328'}], 'facility': 'Kaitai Liu', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'kaitai liu, doctor', 'role': 'CONTACT', 'email': 'liukaitai@nbu.edu.cn', 'phone': '+8613732112205'}, {'name': 'jingtao tong, master', 'role': 'CONTACT', 'email': 'vanssi@163.com', 'phone': '+8615088440328'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo Medical Center Lihuili Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}