Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT05240404
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2022-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656314', 'term': 'toripalimab'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-13', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-02-13', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'up to 3 years until study closed', 'description': 'Disease-free survival was defined as the interval from the date of randomization to date of detection new recurrent disease'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 3 years until study closed', 'description': 'Overall survival (OS) was defined as the interval from the date of randomization to death or study closed'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to approximately 3 years', 'description': 'Evaluation will be done using NCI-CTCAE (version 4.03).'}, {'measure': 'Predictive Biomarkers', 'timeFrame': 'Up to approximately 3 years', 'description': 'Tissue and blood biomarkers in including PD-L1 expression, tumor mutation burden defined as the number of non-inherited mutations per million bases of investigated genomic sequence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Toripalimab'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase II study is to evaluate the efficacy of the adjuvant immunotherapy after curative-intent ablation for recurrent hepatocarcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.\n\nHCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of RT.\n\nliver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7). performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.\n\nWBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \\< 5.0× upper limit of normal; no ascites).\n\nno serious comorbidities other than liver cirrhosis. written informed consent.\n\nExclusion Criteria:\n\nHCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.\n\nHCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of RT.\n\nLiver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7). Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.\n\nWBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \\< 5.0× upper limit.\n\nWritten informed consent.\n\nExlusion criteria:\n\nEvidence of extrahepatic metastasis. Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \\>7). Previous history of other forms of RT adjacent to target tumors. Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score.\n\nPregnant or breast feeding status. Previous history uncontrolled other malignancies within 2 years.'}, 'identificationModule': {'nctId': 'NCT05240404', 'briefTitle': 'Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'A Randomized Phase II Study of Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma', 'orgStudyIdInfo': {'id': 'IRTOE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm A', 'description': 'Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation alone.', 'interventionNames': ['Procedure: Thermal ablation']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation and adjuvant immunotherapy with toripalimab.', 'interventionNames': ['Drug: Toripalimab', 'Procedure: Thermal ablation']}], 'interventions': [{'name': 'Toripalimab', 'type': 'DRUG', 'otherNames': ['Immunotherapy'], 'description': 'toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after ablation for six months', 'armGroupLabels': ['Arm B']}, {'name': 'Thermal ablation', 'type': 'PROCEDURE', 'otherNames': ['Local treatment'], 'description': 'The ablation operation was performed under local or compound anesthesia and guided by ultrasonography (US) or computed tomography (CT). To ensure complete destruction of the tumor, the ablation area must exceed the tumor boundary 1.0 cm.', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410005', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liangrong Shi, M.D.', 'role': 'CONTACT', 'email': 'shiliangr@126.com', 'phone': '8613974886662'}], 'facility': 'Xiangya Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Liangrong Shi, M.D.', 'role': 'CONTACT', 'email': 'shiliangrong@126.com', 'phone': '+8613974886662'}], 'overallOfficials': [{'name': 'Liangrong Shi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangya Hospital of Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}