Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT05766605
Status:
RECRUITING
Last Update Posted:
2023-03-13
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C066228', 'term': 'lobaplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'C068874', 'term': 'raltitrexed'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results, and the control group received postoperative conventional treatment combined with empirical transarterial chemoembolization with Doxorubicin.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The one-year DFS rate', 'timeFrame': 'From the start date of the Treatment until date of the time of 1 year', 'description': 'The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year.'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'From the beginning of therapy until the date of death from any cause(max 24 months)', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma Resectable']}, 'descriptionModule': {'briefSummary': 'This Randomized Controlled Trial was to clarity the clinical feasibility of PDOX results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.', 'detailedDescription': 'Data of Patients who received PDOX after primary liver cancer radical reaction and received Transarterial Chemoembolization #will be collected\n\n#excluding incomplete data. The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Undergone radical surgical resection.\n2. Aged 18-75.\n3. Patients voluntarily cooperated with the study and signed an informed consent form.\n4. Histopathologically diagnosed hepatocellular carcinoma.\n5. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).\n6. Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.\n7. ECOG physical fitness status score of 0-1.\n8. No serious heart, lung, or renal dysfunction\n\nExclusion Criteria:\n\n1. Unable to provide specimens for PDOX testing.\n2. Patients with recurrent liver cancer.\n3. Developing two or more types of tumors simultaneously.\n4. Patients with existing extrahepatic distant metastases.\n5. Treatment with other experimental drugs or other interventions after radical resection.\n6. Patients with other malignant tumors that have not been cured within 5 years.\n7. Patients with non-radical resections (R1 and R2 resections).\n8. Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery.\n9. Died within 1 month after surgery.'}, 'identificationModule': {'nctId': 'NCT05766605', 'briefTitle': 'Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022-KY-298-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the test group', 'description': 'The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 months after surgery.', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Doxorubicin', 'Drug: Lobaplatin', 'Drug: Cisplatin', 'Drug: Oxaliplatin, Leucovorin, fluorouracil', 'Drug: Lobaplatin, Raltitrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the control group', 'description': 'The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 months after surgery.', 'interventionNames': ['Drug: Doxorubicin']}], 'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG', 'description': '130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.', 'armGroupLabels': ['the test group']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': '20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.', 'armGroupLabels': ['the control group', 'the test group']}, {'name': 'Lobaplatin', 'type': 'DRUG', 'description': '50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.', 'armGroupLabels': ['the test group']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '50 mg per square body surface area was used for monthly transhepatic arterial infusions.', 'armGroupLabels': ['the test group']}, {'name': 'Oxaliplatin, Leucovorin, fluorouracil', 'type': 'DRUG', 'description': 'Oxaliplatin(130 mg per square body surface area), Leucovorin(400 mg per square body surface area), and fluorouracil(2800 mg per square body surface area) were used for monthly transhepatic arterial.\n\ninfusions', 'armGroupLabels': ['the test group']}, {'name': 'Lobaplatin, Raltitrexed', 'type': 'DRUG', 'description': 'Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.', 'armGroupLabels': ['the test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510220', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingxin Pan, Prof.', 'role': 'CONTACT', 'email': 'pmxwxy@sohu.com', 'phone': '+8618928918216'}], 'facility': 'Zhujiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Mingxin Pan, Prof.', 'role': 'CONTACT', 'email': 'pmxwxy@sohu.com', 'phone': '+8618928918216'}], 'overallOfficials': [{'name': 'Mingxin Pan, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Principal Investigator Southern Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}