Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-29 @ 8:42 AM
Study NCT ID:
NCT06881433
Status:
RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without HAIC for Advanced HCC
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': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival(OS)', 'timeFrame': 'up to approximately 2 years', 'description': 'The OS is defined as the time from the initiation of any combination treatment to death due to any cause.'}, {'measure': 'Progression free survival(PFS) per RECIST 1.1 or mRECIST', 'timeFrame': 'up to approximately 2 years', 'description': 'The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1 or mRECIST) or death due to any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate(ORR) per RESCIST 1.1', 'timeFrame': 'up to approximately 2 years', 'description': 'The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.'}, {'measure': 'ORR per mRECIST', 'timeFrame': 'up to approximately 2 years', 'description': 'The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.'}, {'measure': 'Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0', 'timeFrame': 'up to approximately 2 years', 'description': 'The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'immune checkpoint inhibitors', 'molecular target therapies', 'hepatic infusion chemotherapy'], 'conditions': ['Hepatocellular Carcinoma (HCC)']}, 'descriptionModule': {'briefSummary': 'Tyrosine kinase inhibitors (TKIs) plus programmed death-1 (PD-1) inhibitors are recommended for patients with advanced hepatocellular carcinoma (HCC) in China. However, these treatments have limited survival benefit in patients with advanced HCC. We aimed to investigate whether hepatic arterial infusion chemotherapy (HAIC) in combination with TKIs and PD-1 inhibitors could improve the efficacy.', 'detailedDescription': 'The multiple real-world studies have shown that Tyrosine kinase inhibitors (TKIs) plus programmed death-1 (PD-1) inhibitors (TKIs-P) does not result in a high response rate or extended survival for patients with extrahepatic metastases, with an objective response rate (ORR) of less than 20%. Therefore, there is an urgent need to explore effective therapeutic strategies that can enhance the combined antitumor efficacy of TKIs-P and improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). In addition to TKIs-P, more aggressive treatments, such as hepatic arterial infusion chemotherapy (HAIC), have been adopted in the Asia-Pacific region. HAIC significantly increases drug concentration in HCC tissues while decreasing drug distribution in the peripheral blood, thereby improving intrahepatic tumor control and reducing systemic adverse events (AEs). Recent significant advancements have been reported in both local-regional and systemic therapies. Furthermore, the combination of HAIC with TKIs-P (HAIC-TKIs-P) may provide potential synergistic anticancer activity for HCC based on the following rationale: HAIC can effectively kill tumors while promoting the release of tumor antigens, thus transforming "cold tumors" into "hot tumors." At the same time, TKIs can reverse the tumor neovascularization induced by interventional therapies and enhance tumor vasculature normalization. However, it remains unclear whether patients with advanced HCC can benefit from HAIC-TKIs -P through intrahepatic lesion control, thereby impeding tumor progression. Accordingly, this national multiple-centers retrospective study aims to compare the clinical benefits and tolerability of HAIC-TKIs-P versus TKIs-P alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with unresectable HCC who received HAIC in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;\n2. Barcelona Clinic Liver Cancer (BCLC) stage B/C;\n3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);\n4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;\n5. HAIC was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);\n6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after HAIC treatment;\n7. Has repeated measurable intrahepatic lesions;\n\nExclusion Criteria:\n\n1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;\n2. Unable to meet criteria of combination timeframe described above;\n3. Child-Pugh C or PS\\>2 or Severe hepatic encephalopathy'}, 'identificationModule': {'nctId': 'NCT06881433', 'briefTitle': 'Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without HAIC for Advanced HCC', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without Hepatic Arterial Infusion Chemotherapy As First-line Treatment for Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CHANCE2504'}}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gao-Jun Teng, M.D', 'role': 'CONTACT', 'email': 'gjteng@vip.sina.com', 'phone': '+86-02583272121'}], 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Gao-Jun Teng, M.D', 'role': 'CONTACT', 'email': 'gjteng@vip.sina.com', 'phone': '+86-02583272121'}, {'name': 'Hai-Dong Zhu, M.D', 'role': 'CONTACT', 'phone': '+86-02583272121'}], 'overallOfficials': [{'name': 'Gao-jun Teng, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda hospital, Southeast university, Nanjing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Gao-jun Teng', 'investigatorAffiliation': 'Zhongda Hospital'}}}}