Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-01 @ 10:23 PM
Study NCT ID:
NCT05025592
Status:
UNKNOWN
Last Update Posted:
2021-09-02
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C559147', 'term': 'regorafenib'}, {'id': 'C000711728', 'term': 'spartalizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-28', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate, ORR', 'timeFrame': '6 months', 'description': 'The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate'}, {'measure': 'Progression free overall survival，PFS', 'timeFrame': '12 months', 'description': 'PFS was defined as the interval between the time at which treatment was initiated and intrahepatic tumor and/or extrahepatic tumor progression, symptomatic progression, including massive ascites and liver function that was categorized as Child-Pugh grade C, or death from any cause'}, {'measure': 'Overall survival，OS', 'timeFrame': '24 months', 'description': 'overall survival (OS) was defined as the interval between the time at which treatment was initiated and death or the last follow-up assessment'}], 'secondaryOutcomes': [{'measure': 'Disease control rate, DCR', 'timeFrame': '6 months', 'description': 'disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['HCC', 'Transarterial Chemoembolization', 'Hepatic Arterial Infusion Chemotherapy', 'Regorafenib']}, 'descriptionModule': {'briefSummary': 'explore the effectiveness and safety of conventional transarterial chemoembolization (cTACE) or transarterial chemoembolization (DEB-TACE) plus hepatic arterial Infusion chemotherapy (HAIC) combined with regorafenib and anti-PD-1 antibody or not for unresected hepatocellular carcinoma (uHCC)', 'detailedDescription': 'This is a non-randomized, open, single-arm clinical study. Patients receive cTACE/DEB-TACE+HAIC treatment( 6-8 weeks as a cycle) and regorafenib and anti-PD1 antibody or not until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with unresectable hepatocellular carcinoma are fail for fisrt line treatment((including but not limited to sorafenib, levatinib, atelizumab combined with bevacizumab, etc.) and will received cTACE/DEB-TACE plus HAIC and regorafenib and anti-PD1 antibody or not.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Volunteer to participate and sign the informed consent in writing;\n2. Age: 18-75 years old;\n3. No gender limit;\n4. Unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis;\n5. Unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.);\n6. At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection;\n7. Child-pugh grade A-B7 grade\n8. The expected survival period is ≥3 months;\n9. General physical condition (ECOG) 0-2;\n10. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×10\\^9/L, neutrophils ≥1.5x 10\\^9/L, platelets ≥80x 10\\^9/L; liver and kidney functions are normal; (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; INR≤1.7 or prolonged PT≤4s.\n\nExclusion Criteria:\n\n1. Those who are currently receiving other effective treatments;\n2. Patients who have received regorafenib in the past;\n3. Patients who have participated in other clinical trials within 4 weeks before enrollment;\n4. Unable to cooperate with cTACE and HAIC treatment;\n5. Patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;\n6. Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year;\n7. Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer;\n8. There were active serious clinical infections (\\>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment;\n9. Known or self-reported HIV infection;\n10. Uncontrolled systemic diseases, such as poorly controlled diabetes;\n11. Known to have hypersensitivity or allergic reactions to any component of the study drug;\n12. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding'}, 'identificationModule': {'nctId': 'NCT05025592', 'briefTitle': 'cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '2021KT83'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody', 'description': 'patients will receive the combination treatment of cTACE/DEB-TACE plus HAIC and combined with regorafenib and anti-PD1 antibody or not. The anti-PD-1 antibody will be used depended on the contraindications or wishes of patients.', 'interventionNames': ['Drug: Regorafenib', 'Device: cTACE/DEB-TACE-HAIC']}], 'interventions': [{'name': 'Regorafenib', 'type': 'DRUG', 'otherNames': ['anti-PD1 antibody'], 'description': 'patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not', 'armGroupLabels': ['cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody']}, {'name': 'cTACE/DEB-TACE-HAIC', 'type': 'DEVICE', 'otherNames': ['conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion'], 'description': 'conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion', 'armGroupLabels': ['cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital Chief Physician，MD', 'investigatorFullName': 'Zhu Xu', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}