Efficacy and Safety of QL1706 Plus Lenvatinib As 2nd Line Theapy in Patients with Metastatic Esophageal Carcinoma After Disease Progression on ICIs Therapy

Launched by THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · Dec 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with metastatic esophageal squamous cell carcinoma (ESCC), a type of cancer that affects the esophagus. Specifically, the trial is looking at the combination of two medications, QL1706 and lenvatinib, for patients whose cancer has progressed after receiving previous treatment with immune checkpoint inhibitors, which are designed to help the immune system fight cancer. The trial aims to understand how effective and safe this new combination treatment is compared to standard options.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of advanced or metastatic ESCC. They should also have experienced progression of their disease after first-line immunotherapy treatment. Participants will need to have at least one measurable tumor to assess the treatment's effects. It’s important to note that individuals with certain autoimmune diseases, severe allergies to similar medications, or those who have experienced severe side effects from previous treatments may not be eligible. For those who qualify, participating in this trial could offer access to a potentially helpful new treatment while contributing to important research in cancer care.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects participate voluntarily and sign informed consent.
• • 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:
• • 1. Presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism)
• • 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