Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:58 PM
Study NCT ID:
NCT04635527
Status:
TERMINATED
Last Update Posted:
2023-03-16
First Post:
2020-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': "Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants experiencing clinical and laboratory adverse events (AEs)', 'timeFrame': 'Up to 90 days post last dose'}], 'secondaryOutcomes': [{'measure': 'The percentage of subjects with pathological Complete Response (pCR) after liver resection', 'timeFrame': '3 years'}, {'measure': 'The percentage of subjects with major pathological response (MPR) after liver resection', 'timeFrame': '3 years'}, {'measure': 'The percentage of subjects with R0 resection', 'timeFrame': '3 years'}, {'measure': 'Objective response rate (ORR) in two arms based on mRECIST by investigator', 'timeFrame': '3 years'}, {'measure': 'Disease-free survival (DFS) in two arms based on mRECIST by investigator', 'timeFrame': '3 years'}, {'measure': 'Overall survival (OS) in two arms', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this phase Ib study is to assess the safety, tolerability and effectiveness of IBI318 in combination with conventional TACE (cTACE) in patients with potentially resected hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥ 18 years and ≤ 75 years at the time of consent.\n2. Hepatocellular carcinoma confirmed by histology/cytology.\n3. Lesions with measurable disease at baseline by mRECIST.\n4. Barcelona Clinic Liver Cancer stage A or B for hepatocellular carcinoma exceeding Milan criteria.\n5. Child-Pugh: \\<=6\n6. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.\n2. Having previously received standard systemic therapy, ablative therapy, interventional therapy and surgical treatment for hepatocellular carcinoma.\n3. Potential liver transplant candidates\n4. Have a history of hepatic encephalopathy or have a history of liver transplantation.\n5. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.'}, 'identificationModule': {'nctId': 'NCT04635527', 'briefTitle': 'A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Phase Ib Study to Evaluate the Safety and Efficacy of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'CIBI318F101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBI318 combined with conventional TACE (cTACE)', 'interventionNames': ['Drug: IBI318', 'Procedure: cTACE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo combined with conventional TACE (cTACE)', 'interventionNames': ['Procedure: cTACE', 'Drug: placebo']}], 'interventions': [{'name': 'IBI318', 'type': 'DRUG', 'description': 'before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W', 'armGroupLabels': ['IBI318 combined with conventional TACE (cTACE)']}, {'name': 'cTACE', 'type': 'PROCEDURE', 'description': 'conventional transarterial chemoembolization', 'armGroupLabels': ['IBI318 combined with conventional TACE (cTACE)', 'Placebo combined with conventional TACE (cTACE)']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W', 'armGroupLabels': ['Placebo combined with conventional TACE (cTACE)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}