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

NOT_YET_RECRUITINGPHASE1/PHASE2

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

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

NCT06746961•The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

January 1, 2025

Primary Completion Date

July 1, 2026

Completion Date

August 1, 2027

Last Updated

December 24, 2024

Enrollment

ESTIMATED participants

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

DRUG

Lenvatinib

DRUG

Contacts

Professor Wang

CONTACT

+86-0371-66913114 zzuwangfeng@zzu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

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