Neoadjuvant QL1706 Therapy for ESCC
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.
Timeline
- Start
- 2025-04-28
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iparomlimab and Tuvonralimab | Unknown | 5 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 260 mg/m2 | — |