NCT06852456

QL1706 in Combination With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

A PhaseⅡ/Ⅲ, Randomized, Double-blind, Placebo-controlled Trial to Evaluate QL1706 Perioperative Treatment in Combination With Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the perioperative treatment with QL1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. The primary objective of the Phase II is to evaluate the pathological complete response rate of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the Phase III is to compare event-free survival of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.

Conditions

• Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab (QL1706)Injection	PD-1/CTLA-4
DRUG	Paclitaxel	Chemotherapy
DRUG	Cisplatin	Chemotherapy

Timeline

• Start date: 2025-03-01
• Primary completion: 2030-12-01
• Completion: 2034-12-01
• First posted: 2025-02-28
• Last updated: 2025-02-28