Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-12 @ 10:01 AM
Study NCT ID:
NCT05864105
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
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': 'C410216', 'term': 'Folfox protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD-L1/VEGF', 'FOLFOX-4'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.', 'detailedDescription': 'PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;\n2. Male or female aged \\>= 18 years;\n3. HCC diagnosed by pathology or clinical;\n4. BCLC stage C or B (unresectable or/and not suitable for local therapy);\n5. Child-Pugh score \\<= 7;\n6. ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;\n2. Symptomatic CNS metastases, not suitable for the study assessed by investigator;\n3. Evidence of major coagulopathy or other obvious risk of bleeding;\n4. Unable to accept enhanced imaging examination (CT or MRI) for any reason;\n5. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;\n6. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;\n7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n8. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;\n9. Patients with psychiatric disorders or poor compliance;\n10. Women who are pregnant or breastfeeding;\n11. The condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and AE;\n12. Other conditions lead to inappropriate to participate in this study as judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT05864105', 'briefTitle': 'PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotheus Inc.'}, 'officialTitle': 'A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in Unresectable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'PM8002 -B006C-HCC-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PM8002+FOLFOX-4', 'description': 'PM8002 20mg/kg Q2W day 1: oxaliplatin \\[85 mg/m2, 2-h infusion\\] plus leucovorin \\[200 mg/m2, 2-h infusion\\], followed by 5-fluorouracil \\[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\\]; day 2: leucovorin \\[200 mg/m2, 2-h infusion\\], followed by 5-fluorouracil \\[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\\]', 'interventionNames': ['Biological: PM8002', 'Drug: FOLFOX regimen']}], 'interventions': [{'name': 'PM8002', 'type': 'BIOLOGICAL', 'description': 'PM8002 20mg/kg Q2W', 'armGroupLabels': ['PM8002+FOLFOX-4']}, {'name': 'FOLFOX regimen', 'type': 'DRUG', 'description': 'day 1: oxaliplatin \\[85 mg/m2, 2-h infusion\\] plus leucovorin \\[200 mg/m2, 2-h infusion\\], followed by 5-fluorouracil \\[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\\]; day 2: leucovorin \\[200 mg/m2, 2-h infusion\\], followed by 5-fluorouracil \\[400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion\\]', 'armGroupLabels': ['PM8002+FOLFOX-4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Cancer Hospital of The University of Chinese Academy of Sciences', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Jinhua Municipal Centeral Hospital Medical Group', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}], 'overallOfficials': [{'name': 'Jieer Ying', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital of The University of Chinese Academy of Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data will be published or presented for publications (poster, abstract, articles or papers) or any presentations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotheus Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}