Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT06984718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-22
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC
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': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) per RECIST v1.1 by Blinded Independent Central Review (BICR)', 'timeFrame': 'Up to 24 months', 'description': 'Proportion of subjects who have a complete or partial response relative to baseline as assessed by BICR according to RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 24 months', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'Progression-free survival (PFS) assessed by investigator per RECIST v1.1', 'timeFrame': 'Up to 24 months', 'description': 'PFS is defined as the time from randomization till the first documented disease progression (Per RECIST v1.1 assessed by the investigator) or death due to any cause, whichever occurs first.'}, {'measure': 'Duration of Response (DOR) assessed by investigator per RECIST v1.1', 'timeFrame': 'Up to 24 months', 'description': 'DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.'}, {'measure': 'Time to Response (TTR) assessed by investigator per RECIST v1.1', 'timeFrame': 'Up to 24 months', 'description': 'TTR refers to Time to Response.'}, {'measure': 'Number of participants with adverse event (AE)', 'timeFrame': 'Up to 24 months', 'description': 'The number of participants experiencing an Adverse Event (AE) and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HCC', 'Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a Phase II, randomized, open-label, global, multi-center study to compare the efficacy and safety of AK104 in combination with lenvatinib versus lenvatinib in patients with advanced hepatocellular carcinoma who have progressed on the first line treatment of atezolizumab and bevacizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed the Informed Consent Form (ICF) voluntarily.\n2. Age ≥18 years at time of signing ICF.\n3. Histologic or cytologic confirmation of HCC, or clinical diagnosis of HCC as per AASLD criteria.\n4. BCLC stage B or C, and not suitable for curative surgical or local therapy.\n5. Participants have progressed on the prior first-line systemic treatment with atezolizumab plus bevacizumab combination treatment.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Child-Pugh Class A .\n8. ECOG performance status of 0 or 1.\n9. With a life expectancy of ≥3 months.\n10. Adequate organ and hematologic function.\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n2. Tumor thrombus invasion of superior mesenteric vein.\n3. Has a known history of, or any evidence of CNS metastases.\n4. Has received anti-cancer therapy for HCC within 3 weeks prior to the first dose of study treatment.\n5. Has received systemic anti-cancer therapy other than atezolizumab and bevacizumab.\n6. Has participated in another clinical study within 4 weeks prior to the first dose.\n7. History of liver transplantation.\n8. History of hepatic encephalopathy.\n9. Clinically symptomatic or recurrently drained pleural effusion, pericardial effusion, or ascites.\n10. History of bleeding event due to esophageal and/or gastric varices within 6 months prior to the first dose of study treatment.'}, 'identificationModule': {'nctId': 'NCT06984718', 'briefTitle': 'A Phase II Study of AK104 Combination With Lenvatinib Versus Lenvatinib for Second-line HCC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': 'A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination With Lenvatinib Versus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab', 'orgStudyIdInfo': {'id': 'AK104-225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK104+lenvatinib', 'description': 'AK104 IV plus lenvatinib orally', 'interventionNames': ['Biological: AK104+lenvatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lenvatinib', 'description': 'lenvatinib orally', 'interventionNames': ['Drug: lenvatinib']}], 'interventions': [{'name': 'AK104+lenvatinib', 'type': 'BIOLOGICAL', 'description': 'Subjects will receive AK104+lenvatinib until disease progression', 'armGroupLabels': ['AK104+lenvatinib']}, {'name': 'lenvatinib', 'type': 'DRUG', 'description': 'Subjects will receive lenvatinib until disease progression', 'armGroupLabels': ['lenvatinib']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ting Liu, M.D.', 'role': 'CONTACT', 'email': 'clinicaltrials@akesobio.com', 'phone': '(0760)89873999'}], 'overallOfficials': [{'name': 'Richard S. Finn, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, University of California'}, {'name': 'Jian Zhou, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akeso', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}