Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy
NCT ID: NCT06746961
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
49 participants
INTERVENTIONAL
2025-01-31
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QL1706 plus Lenvatinib
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.
Lenvatinib will be administrated at a dose of 8 mg or 12mg orally (PO) once daily (QD)
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
5mg/kg , iv, q3w
Lenvatinib
8 mg or 12 mg QD via oral capsule
Interventions
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QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
5mg/kg , iv, q3w
Lenvatinib
8 mg or 12 mg QD via oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 18-75 years, male or female.
3. Histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma
4. Patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-PD-1/PD-L1 antibodies
5. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).
6. ECOG PS 0-1
Exclusion Criteria
2. 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
3. Severe allergic reaction to other monoclonal antibodies
4. Those who terminated treatment due to related toxicity during anti-PD-1/PD-L1 antibody treatment
5. Prior treatment with bispecific anti-PD-1/CTLA-4 checkpoint blockades or VEGFR inhibitors
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Responsible Party
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Feng Wang
Professor
Central Contacts
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Other Identifiers
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QLMA-EC-IIT-001
Identifier Type: -
Identifier Source: org_study_id