Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-26 @ 5:55 AM
Study NCT ID:
NCT07078292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of First-line Treatment Combined With Immunotherapy for Advanced Hepatocellular Carcinoma: a Single Center, Real-world Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2025-07-13', 'studyFirstSubmitQcDate': '2025-07-13', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '6 months', 'description': 'Objective response rate'}], 'secondaryOutcomes': [{'measure': 'DCR', 'timeFrame': '6 months', 'description': 'Disease Control Rate'}, {'measure': 'Conversion surgery rate', 'timeFrame': '6 months'}, {'measure': 'PFS', 'timeFrame': '12 months', 'description': 'Progression free survival'}, {'measure': 'Overall survival (OS)', 'timeFrame': '24 months'}, {'measure': 'AE', 'timeFrame': '12 months', 'description': 'Adverse events'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Immunotherapy', 'Real world study'], 'conditions': ['Hepatocellular Carcinoma (HCC)', 'Real World Study']}, 'descriptionModule': {'briefSummary': 'In recent years, immunotherapy represented by PD-1/PD-L1 inhibitors has continuously brought breakthroughs in the treatment of hepatocellular carcinoma and has gradually become the cornerstone of advanced liver cancer treatment. With positive results from the IMbrave-150 study, the combination of atezolizumab and bevacizumab has been approved for first-line treatment of advanced HCC. Subsequently, multiple immune combination therapy regimens were approved one after another, enriching the first-line treatment options for advanced HCC. At present, combination therapy based on immune checkpoint inhibitors has become the mainstream first-line treatment for advanced HCC, and three main treatment modes have been formed: immune combined with bevacizumab, immune combined with TKI, and immune combined with immunity.\n\nMultiple immune combination therapy regimens have shown a flourishing trend in clinical trials, which has brought some thought-provoking issues to the clinical practice of first-line treatment for advanced HCC. On the one hand, the above studies all used sorafenib/lenvatinib monotherapy as a control, lacking a "head to head" comparison. In real-world scenarios, how to choose between different treatment options depends on the judgment of clinical doctors and drug accessibility, lacking support from research data. On the other hand, the ORR of immune combination therapy is between 20% and 40%, and there are still a large number of patients who have initial treatment resistance to the above regimen and cannot achieve satisfactory therapeutic effects. How to accurately predict/identify the response of different populations to different treatment regimens, and then carry out personalized treatment, is also an important issue facing the first-line treatment of advanced HCC. In addition to systemic anti-tumor therapy, local treatment (such as TACE, HAIC, ablation, radiotherapy, etc.) and surgical treatment are also advantageous weapons for treating advanced HCC, complementing systemic treatment to further improve the prognosis of advanced HCC. However, more clinical research evidence is still needed to support the clinical efficacy data of local treatment combined with systemic treatment in the field of advanced HCC treatment.\n\nBased on the above clinical issues, this study intends to retrospectively and prospectively collect advanced HCC patients who receive first-line immunotherapy in our center, explore the effectiveness and safety of combination therapy based on immune checkpoint inhibitors for first-line treatment of advanced hepatocellular carcinoma in the real world, and reveal the advantageous treatment populations of different immunotherapy regimens (immune+bevacizumab, immune+TKI, immune+immune) in the real world, in order to provide some data reference for the first-line treatment population and regimen selection of advanced HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Advaced hepatocellular carcinoma patients，BCLC stage B-C；CNLC stage IIA-IIIB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old, male or female not limited\n* Non resectable HCC patients diagnosed by tissue/cytology or imaging that meets the diagnostic criteria for HCC\n* There must be at least one measurable lesion (RECIST 1.1)\n* Use immunotherapy combination therapy as first-line treatment, including atezolizumab+bevacizumab, sintilizumab+bevacizumab analogs, carrelizumab+apatinib, lenvatinib+tirelizumab or sintilizumab, with or without local treatment (including but not limited to TACE, HAIC)\n* Have not received systematic anti-tumor treatment in the past\n* Child Pugh 5-7 points\n* ECOG PS 0-1 points\n* Prospective cohort requires patients to have at least one imaging tumor evaluation since baseline;\n\nExclusion Criteria:\n\n* Lack of baseline data and post-treatment imaging data\n* With other malignant tumors\n* Merge severe cardiovascular diseases and uncontrollable infections\n* Existence of any active autoimmune disease or history of autoimmune disease Expected survival period\\<3 months'}, 'identificationModule': {'nctId': 'NCT07078292', 'briefTitle': 'The Efficacy and Safety of First-line Treatment Combined With Immunotherapy for Advanced Hepatocellular Carcinoma: a Single Center, Real-world Study', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'The Efficacy and Safety of First-line Treatment Combined With Immunotherapy for Advanced Hepatocellular Carcinoma: a Single Center, Real-world Study', 'orgStudyIdInfo': {'id': 'E20250416'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immunotherapy combined with bevacizumab ± TACE/HAIC'}, {'label': 'immunotherapy combined with TKI ± TACE/HAIC'}, {'label': 'immunotherapy combined with immunotherapy ± TACE/HAIC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}