Neoadjuvant QL1706 Therapy for ESCC

This study plans to enroll 32 patients with resectable esophageal squamous cell carcinoma. The treatment regimen consists of Iparomlimab and Tuvonralimab(QL1706) combined with chemotherapy: intravenous infusion of QL1706 (5 mg/kg, q3w) in combination with albumin-bound paclitaxel (260 mg/m² on day 1, q3w) plus cisplatin (75 mg/m² on day 1, q3w) or carboplatin (AUC 5 on day 1, q3w) for 3 cycles. Surgical resection will be performed 3-6 weeks after treatment completion. Pre-treatment and surgical tissue specimens will be collected for analysis of tumor immune microenvironment changes using digital gene quantification technology. Peripheral blood samples will be obtained for dynamic ctDNA monitoring at four time points: within 7 days pre-treatment, 7 days pre-surgery, 7-30 days post-surgery, and 6 months post-surgery. The primary endpoint is the pathological complete response (pCR) rate, and secondary endpoints include major pathological response (MPR) and adverse reactions.

NCT Number	NCT06908382
Lead Sponsor	Shandong Provincial Hospital
Conditions	Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Enrollment	32 participants
Start Date	2025-04-28
Primary Completion	2026-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-18