Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT06537505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'explore immune resistance mechanisms', 'timeFrame': 'up to 36 months', 'description': 'to explore immune resistance mechanisms'}], 'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'up to 24 months', 'description': 'Determined using RECIST V1.1 criteria, defined as best overall response (CR or PR)'}], 'secondaryOutcomes': [{'measure': 'Disease control rate', 'timeFrame': 'up to 24 months', 'description': 'Disease Control Rate determined usina RECIST V1.1 criteria.'}, {'measure': 'Progression-free Survival', 'timeFrame': 'up to 36 months', 'description': 'Defined as the time from randomization to the first occurrence of disease progression'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 36 months', 'description': 'Defined as the time from randomization to death from any cause.'}, {'measure': 'incidence rate of AE', 'timeFrame': 'up to 36 months', 'description': 'Incidence, nature, and severity of adverse events graded according to the NCI CCAE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, phase Il trial to evaluate the efficacy and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs in the treatment of advanced second-line and above solid tumors.', 'detailedDescription': 'This study plans to recruit 60 patients witha dvanced second-line and above solid tumors observe and evaluate the effectiveness and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with clinically confirmed advanced non-small cell lung cancer or hepatocellular carcinoma;\n2. Previously received systemic treatment;\n3. Expected survival period \\> 3 months;\n4. Age: 18-75 years old, male or female;\n5. ECOG PS: 0-2 points;\n6. The function of important organs meets the following requirements: a) Absolute neutrophil count ≥1.5×109/L, platelet ≥90×109/L, hemoglobin ≥90g/dL; b) Bilirubin ≤3 times ULN (patients drained by retrograde technique can be included); ALT and AST ≤5 times ULN, albumin\\>35g/ml, prothrombin time prolonged \\<6 seconds; c) Creatinine \\<120 μmol/L, or MDRD creatinine clearance \\>60 mL/min;\n7. Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing age and men (having sexual relations with women of childbearing age) must agree to use effective contraceptive measures uninterruptedly during treatment and for 6 months after the last treatment dose;\n8. The patient voluntarily joined this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients who have had other malignant tumors in the past or at the same time within 5 years, but excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial or non-invasive bladder cancer, etc.\n2. Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term;\n3. Patients with severe pulmonary fibrosis and pulmonary hypertension;\n4. Patients with infectious and radioactive inflammation around the lesion and skin infection at the puncture site that is not well controlled;\n5. Systemic infection, high fever \\>38.5 ℃;\n6. Severe anemia, dehydration and severe nutritional metabolism disorder that cannot be corrected or improved in a short period of time;\n7. Poorly controlled malignant pleural effusion;\n8. Uncontrolled, symptomatic brain metastasis or a history of difficult-to-control mental illness or severe intellectual or cognitive impairment;\n9. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;\n10. Congestive heart failure, uncontrollable arrhythmias, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;\n11. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;\n12. History of psychotropic drug abuse, alcoholism or drug abuse;\n13. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive;\n14. Those who are considered by the researchers to be unsuitable for participation in this trial.'}, 'identificationModule': {'nctId': 'NCT06537505', 'briefTitle': 'A Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Beidahuang Industry Group General Hospital'}, 'officialTitle': 'An Exploratory Clinical Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Advanced Second-line and Above Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-1316-HLJ-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microwave ablation combined with immunotherapy and anti-angiogenic drugs', 'description': 'microwave ablation combined with adebrelimab and apatinib', 'interventionNames': ['Drug: Adebrelimab', 'Drug: Apatinib', 'Procedure: microwave ablation']}, {'type': 'EXPERIMENTAL', 'label': 'microwave ablation combined with immunotherapy', 'description': 'microwave ablation combined with adebrelimab', 'interventionNames': ['Drug: Adebrelimab', 'Procedure: microwave ablation']}], 'interventions': [{'name': 'Adebrelimab', 'type': 'DRUG', 'otherNames': ['SHR-1316'], 'description': 'Q3W,IV', 'armGroupLabels': ['microwave ablation combined with immunotherapy', 'microwave ablation combined with immunotherapy and anti-angiogenic drugs']}, {'name': 'Apatinib', 'type': 'DRUG', 'description': 'QoD', 'armGroupLabels': ['microwave ablation combined with immunotherapy and anti-angiogenic drugs']}, {'name': 'microwave ablation', 'type': 'PROCEDURE', 'description': 'microwave ablation', 'armGroupLabels': ['microwave ablation combined with immunotherapy', 'microwave ablation combined with immunotherapy and anti-angiogenic drugs']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mingyang Liu', 'role': 'CONTACT', 'email': 'redrumff@163.com', 'phone': '+86 451 5519 7857'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beidahuang Industry Group General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician', 'investigatorFullName': 'LiuMingyang', 'investigatorAffiliation': 'Beidahuang Industry Group General Hospital'}}}}