Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-21 @ 10:00 PM
Study NCT ID:
NCT05898256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate(ORR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.'}, {'measure': 'Incidence and severity of adverse events(AEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Incidence and severity of AEs is aim to evaluate the safety of Cadonilimab in combination with chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma', 'Immune Checkpoint Inhibitors']}, 'descriptionModule': {'briefSummary': 'This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Cadonilimab in combination with gemcitabine/cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject must sign the written informed consent form (ICF) voluntarily；\n2. Age ≥18 years and ≤65 years；\n3. Subjects with histopathological diagnosis of nasopharyngeal carcinoma；\n4. Primarily metastatic (stage IVB as defined by AJCC staging system for NPC, eighth edition) or recurrent/metastatic NPC that is not amenable to local regional treatment or curative treatment and at least 6 months after radical treatment；\n5. Has not received prior systemic treatment;\n6. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status\n7. Subject must have a measurable target lesion based on RECIST v1.1;\n\nExclusion Criteria:\n\n1. Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;\n2. Prior therapy as follow:\n\n Anti-PD-1, anti-PD-L1 or anti-CTLA-4; Concurrent medical condition requiring the use of cortisol (\\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment（Except：inhalation or topical corticosteroids）.\n3. Any active malignancy ≤ 2 years before randomization except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)；\n4. Female patients who are at pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT05898256', 'briefTitle': 'Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'officialTitle': 'A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Cadonilimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'GuangxiMUHK4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bispecific Antibody + GP Group', 'description': 'Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 years；\n\nGemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cycles；\n\nCisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles.', 'interventionNames': ['Drug: Cadonilimab', 'Drug: Gemcitabine', 'Drug: Cisplatin']}], 'interventions': [{'name': 'Cadonilimab', 'type': 'DRUG', 'otherNames': ['AK104'], 'description': '10mg/kg administered intravenously (IV)', 'armGroupLabels': ['Bispecific Antibody + GP Group']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': '1 g/m2, administered as an IV infusion within 30 minutes', 'armGroupLabels': ['Bispecific Antibody + GP Group']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '80 mg/m2, administered as an IV infusion over 4 hours', 'armGroupLabels': ['Bispecific Antibody + GP Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'kai hu, professor', 'role': 'CONTACT', 'email': 'gxhukai@hotmail.com', 'phone': '+867715356509'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Kai Hu', 'investigatorAffiliation': 'Guangxi Medical University'}}}}