Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-01 @ 9:35 PM
Study NCT ID:
NCT07180459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'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': 'C000710249', 'term': 'donafenib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 118}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'up to 1 year', 'description': 'The definition of PFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 1 year', 'description': 'ORR is defined as the proportion of patients who achieve complete remission (CR, Complete Response) and partial remission (PR, Partial Response) according to the mRECIST criteria'}, {'measure': 'OS', 'timeFrame': 'up to1 year', 'description': 'The OS is defined as the time from the first administration of combined therapy to the occurrence of any cause of death. If there is no death record for the patient, the last visit time will be used as the censored value.'}, {'measure': 'TTP', 'timeFrame': 'up to1 year', 'description': 'The TTP is defined as the time from the first administration of combined therapy to the first imaging assessment revealing tumor progression'}, {'measure': 'AE', 'timeFrame': 'up to1 year', 'description': 'Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carcinoma', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To clarify the safety and efficacy of using uniform-sized drug-loaded embolic microspheres (E-TACE) of different particle sizes for graded embolization during TACE combined with Donafenib in the treatment of unresectable primary liver cancer. To determine whether this therapy can prolong the ORR, DCR, PFS, OS and other indicators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '118 Hepatocellular carcinoma Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Patients with unresectable primary liver cancer who strictly meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines" (2024 Edition) or who have been diagnosed through pathological histology or cytology examination, and who have at least one measurable lesion (according to the mRECIST 1.1 version, the long diameter of the measurable lesion on spiral CT scan should be ≥ 10mm or the short diameter of the enlarged lymph node should be ≥ 15mm); (2) Tumor staging: CNLC stage Ib, IIa, IIb, IIIa, IIIb or BCLC A, B, C stage; non-diffuse liver cancer (PVTT classified according to the Japanese Liver Cancer Research Society\'s portal vein tumor thrombus characteristics as Vp1/2, Vp3, Vp4); (3) Gender of the patients is not restricted, and the age is 18-80 years old; expected lifespan is ≥ 3 months; (4) Within 1 week before enrollment, the ECOG PS score: 0-1; (5) No severe comorbidities, such as hypertension, coronary heart disease and history of mental illness, no severe allergy history; (6) Liver function should reach Child-Pugh grade A or B; (7) Laboratory tests meet the following requirements: platelets ≥ 50×109/L; hemoglobin ≥ 9g/dL; white blood cells ≥ 4×109/L; neutrophils ≥ 1.5×109/L); serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine shows urine protein \\< 2+; for patients whose urine protein ≥ 2+ at baseline, 24-hour urine collection should be conducted and the 24-hour urine protein quantification \\< 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; (8) HBV DNA \\< 2000 IU/ml (104 copies/ml); (9) For pregnant women of childbearing age, a pregnancy test should be conducted within 7 days before enrollment; (10) Patients have signed the informed consent form agreeing to participate in this trial study; good compliance and cooperation with treatment.\n\nExclusion Criteria:\n\n* (1) Imaging examination shows that the liver tumor is huge (≥ 60% of liver volume), or there is a main portal vein tumor thrombus (occupying the vascular diameter ≥ 50%), or the tumor thrombus invades the mesenteric vein or inferior vena cava, or there are obvious native hepatic artery - portal vein fistulas and native hepatic artery - hepatic vein fistulas that cannot safely use drug-loaded microspheres; (2) Before participating in this study, they have undergone local treatments such as traditional TACE, thermal ablation, cryoablation, external radiotherapy and radioactive particle implantation, and have received systemic chemotherapy, oral liver cancer targeted drugs (sorafenib, lenafolate, apatinib) and immune therapy (PD-1/PD-L1/CDLA-4/biologic double therapy); (3) Patients with diffuse liver cancer; known hepatocellular carcinoma and mixed cell carcinoma and fibroplastic cell carcinoma; having other untreated malignant tumors in the past (within 5 years) or simultaneously; except for cured skin basal cell carcinoma and cervical carcinoma in situ; (4) Having grade II or above myocardial ischemia or myocardial infarction, and uncontrolled arrhythmia (including QTc interval for males ≥ 450ms, females ≥ 470ms); (5) Having a history of gastrointestinal bleeding in the past 6 months or having a clear tendency for gastrointestinal bleeding, such as: esophageal varices with bleeding risk, local active ulcer lesion, fecal occult blood ≥ (++), not eligible for inclusion; if fecal occult blood (+), a gastroscopy examination is required; (6) Abnormal coagulation function (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds), bleeding tendency or undergoing thrombolysis or anticoagulation treatment; (7) Patients with central nervous system metastasis or known brain metastasis; having objective evidence of past and current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of pulmonary function; patients with combined HIV infection; pregnant or lactating patients; patients preparing for liver transplantation (except for patients who have undergone liver transplantation in the past); (8) Severe systemic failure, with an expected survival period \\< 3 months; (9) Severe renal dysfunction (creatinine \\> 2mg/dl or creatinine clearance rate \\< 30ml/min); (10) Unable to complete the treatment plan due to various reasons, and lost follow-up within three months after enrollment.'}, 'identificationModule': {'nctId': 'NCT07180459', 'briefTitle': 'The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'The Treatment of Unresectable Liver Cancer With Graded Embolization of Uniform-sized Drug-loaded Microspheres Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study', 'orgStudyIdInfo': {'id': '2025-KY-1085-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'E-TACE in Combination with Donafenib', 'interventionNames': ['Procedure: E-TACE', 'Drug: Donafenib']}], 'interventions': [{'name': 'E-TACE', 'type': 'PROCEDURE', 'description': 'The 70/100μm drug-loaded microspheres were loaded with anthracyclines (30mg-50mg Idarubicin) at 2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded anthracyclines (30mg-50mg Idarubicin) with 2mL/3mLto embolize the tumor supplying arteries at different grades and diameters.', 'armGroupLabels': ['E-TACE in Combination with Donafenib']}, {'name': 'Donafenib', 'type': 'DRUG', 'description': '400mg QD', 'armGroupLabels': ['E-TACE in Combination with Donafenib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': "People's Hospital of Kaiyang County", 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Hainan Medical Universsity', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Kaifeng', 'state': 'Henan', 'country': 'China', 'facility': 'Huai He Hospital of Henan University', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}, {'city': 'Luohe', 'state': 'Henan', 'country': 'China', 'facility': 'Luo He Central Hospital', 'geoPoint': {'lat': 33.56394, 'lon': 114.04272}}, {'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'Luo Yang Central Hospital', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'facility': "Deng zhou People's Hospital", 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'city': 'Shangqiu', 'state': 'Henan', 'country': 'China', 'facility': "First People's Hospital of Shangqiu", 'geoPoint': {'lat': 34.45, 'lon': 115.65}}, {'city': 'Zhoukou', 'state': 'Henan', 'country': 'China', 'facility': 'Zhou Kou Central Hospital', 'geoPoint': {'lat': 33.63333, 'lon': 114.63333}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Provincial People's Hospitail", 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Jiaozuo', 'country': 'China', 'facility': "Second People's Hospital of Jiaozuo", 'geoPoint': {'lat': 35.23925, 'lon': 113.23914}}], 'centralContacts': [{'name': 'Xuhua Duan Duan', 'role': 'CONTACT', 'email': 'xuhuaduan@163.com', 'phone': '+86 13523402912'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuhua Duan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The First Affiliated Hospital of Zhengzhou University', 'investigatorFullName': 'Xuhua Duan', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}