Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-28 @ 2:07 AM
Study NCT ID:
NCT06089369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
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': 'C000632826', 'term': 'sintilimab'}, {'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-28', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-Free Survival (RFS)', 'timeFrame': 'Randomization up to 60 months', 'description': 'RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).'}], 'secondaryOutcomes': [{'measure': 'RFS Rate at 12 ,24 , 36 , 60 Months', 'timeFrame': 'Randomization up to 60 months', 'description': 'RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Randomization up to 60 months', 'description': 'OS is defined as the time from randomization to death from any cause'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline up to 60 months', 'description': 'The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0'}, {'measure': 'Quality of Life (QoL) Scale Score', 'timeFrame': 'Baseline up to 60 months', 'description': 'Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death 1', 'Checkpoint Inhibitor', 'Immunotherapy', 'Adjuvant', 'Hepatocellular Carcinoma', 'Microvascular Invasion'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.', 'detailedDescription': 'This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a histopathological diagnosis of HCC\n* Undergone a curative resection\n* Pathologically confirmed HCC with microvascular invasion (MVI)\n* Aged 18-75 years\n* No previous systematic treatment and locoregional therapy for HCC prior to randomization\n* Absence of major macrovascular invasion\n* No extrahepatic spread\n* Full recovery from Curative resection within 4 weeks prior to randomization\n* Child-Pugh: Grade A or B(7)\n* ECOG-PS score: 0 or 1\n* Subjects with HCV- RNA (+) must receive antiviral therapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC\n* Any preoperative treatment for HCC including local and systemic therapy\n* Have received more than 1 cycle of adjuvant TACE following surgical resection\n* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency\n* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug\n* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy\n* Cardiac clinical symptom or cardiovascular disease that is not well controlled\n* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment\n* Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months\n* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment\n* Inability or refusal to comply with the treatment and monitoring'}, 'identificationModule': {'nctId': 'NCT06089369', 'briefTitle': 'Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study', 'orgStudyIdInfo': {'id': 'Adjuvant-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sintilimab for six months group (9 cycles)', 'description': 'Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred.', 'interventionNames': ['Drug: Sintilimab (9 cycles)']}, {'type': 'EXPERIMENTAL', 'label': 'Sintilimab for one year group (18 cycles)', 'description': 'Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred.', 'interventionNames': ['Drug: Sintilimab (18 cycles)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active surveillance', 'description': 'Patients are closely monitored postoperatively.', 'interventionNames': ['Other: Active surveillance']}], 'interventions': [{'name': 'Sintilimab (9 cycles)', 'type': 'DRUG', 'otherNames': ['IBI 308'], 'description': 'IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles）', 'armGroupLabels': ['Sintilimab for six months group (9 cycles)']}, {'name': 'Sintilimab (18 cycles)', 'type': 'DRUG', 'otherNames': ['IBI 308'], 'description': 'IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles）', 'armGroupLabels': ['Sintilimab for one year group (18 cycles)']}, {'name': 'Active surveillance', 'type': 'OTHER', 'description': 'Active surveillance', 'armGroupLabels': ['Active surveillance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xiaoping Chen, Prodessor', 'role': 'CONTACT', 'email': 'chenxpchenxp@163.com', 'phone': '02783665213'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chen Xiaoping', 'investigatorAffiliation': 'Tongji Hospital'}}}}