Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-31 @ 6:59 PM
Study NCT ID:
NCT06746961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D)', 'timeFrame': 'up to ~21 days', 'description': 'Hematologic DLTs are defined as:\n\n1. Grade 4 neutropenia lasting for ≥7 days\n2. febrile neutropenia not associated with the underlying disease,\n3. Grade 3 thrombocytopenia with bleeding, Grade ≥3 thrombocytopenia requiring platelet transfusion, Grade 4 thrombocytopenia, .'}, {'measure': 'Phase II: Overall Survival (OS) in all participants', 'timeFrame': 'up to ~48 months', 'description': 'OS is defined as the time from the first administration to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'up to ~42 months', 'description': 'PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first.'}, {'measure': 'ORR', 'timeFrame': 'up to ~42 months', 'description': 'ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.'}, {'measure': 'DOR', 'timeFrame': 'up to ~42 months', 'description': 'For participants who demonstrate a confirmed CR or PR, per RECIST 1.1 by the investigators, DOR is defined as the time from first documented evidence of CR or PR until PD or death.'}, {'measure': 'Number of Participants With AEs', 'timeFrame': 'Up to ~53 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['QL1706', 'lenvatinib', 'immune checkpoint blockades', 'esophageal squamous cell carcinoma', 'ESCC'], 'conditions': ['Esophageal Squamous Cell Carcinoma (ESCC)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of QL1706 plus lenvatinib in second-line therapy for patients with metastatic esophageal squamous cell carcinoma after progression on immune checkpoint inhibitor therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects participate voluntarily and sign informed consent.\n2. 18-75 years, male or female.\n3. Histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma\n4. Patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-PD-1/PD-L1 antibodies\n5. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).\n6. ECOG PS 0-1\n\nExclusion Criteria:\n\n1. Presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)\n2. Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\\> 10 mg/day prednisone or other equivalent cortiremonial hormones) and are taking within 2 weeks before recruitment\n3. Severe allergic reaction to other monoclonal antibodies\n4. Those who terminated treatment due to related toxicity during anti-PD-1/PD-L1 antibody treatment\n5. Prior treatment with bispecific anti-PD-1/CTLA-4 checkpoint blockades or VEGFR inhibitors'}, 'identificationModule': {'nctId': 'NCT06746961', 'briefTitle': 'Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'A Single-arm, Open-label, Multicenter Phase Ⅰb/Ⅱ Clinical Study of QL1706 (bispecific Antibody Targeting PD-1 and CLTA-4) in Combination with Lenvatinib in Second-line Therapy for Advanced Esophageal Squamous Cell Carcinoma After Disease Progression on Immune Checkpoint Blockades Therapy', 'orgStudyIdInfo': {'id': 'QLMA-EC-IIT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QL1706 plus Lenvatinib', 'description': 'QL1706 will be administrated at a dose of 5 mg/kg intravenously (IV), every 3 weeks, until progressive disease or intolerable or other reasons according to the criteria for termination of treatment. QL1706 will be administrated up to 2 year.\n\nLenvatinib will be administrated at a dose of 8 mg or 12mg orally (PO) once daily (QD)', 'interventionNames': ['Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4)', 'Drug: Lenvatinib']}], 'interventions': [{'name': 'QL1706 (bispecific antibody targeting PD-1 and CLTA-4)', 'type': 'DRUG', 'description': '5mg/kg , iv, q3w', 'armGroupLabels': ['QL1706 plus Lenvatinib']}, {'name': 'Lenvatinib', 'type': 'DRUG', 'otherNames': ['MK-7902', 'E7080', 'LENVIMA'], 'description': '8 mg or 12 mg QD via oral capsule', 'armGroupLabels': ['QL1706 plus Lenvatinib']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Professor Wang', 'role': 'CONTACT', 'email': 'zzuwangfeng@zzu.edu.cn', 'phone': '+86-0371-66913114'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Feng Wang', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}