NCT06908382

Neoadjuvant QL1706 Therapy for ESCC

A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection	QL1706 (5 mg/kg, q3w) +Paclitaxel for injection (albumin bound) (260mg/m2 D1, q3w)+cisplatin (75mg/m2 D1, q3w)/carboplatin (AUC 5 D1) ， 3 cycles

Timeline

• Start date: 2025-04-28
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-04-03
• Last updated: 2025-04-18

Locations

1 site across 1 country: China