NCT07049185

QL1706 Plus Celecoxib in Advanced Esophageal Squamous Cell Carcinoma

A Single-Arm Clinical Trial of QL1706 Combined With Celecoxib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Prior ICI Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, Simon's two-stage phase II clinical trial to evaluate the efficacy and safety of QL1706 (a dual PD-1 and CTLA-4 antibody) combined with celecoxib in patients with advanced esophageal squamous cell carcinoma (ESCC) who progressed after prior immune checkpoint inhibitor therapy.

Detailed description

The study aims to explore whether the combination of QL1706 and celecoxib can improve the objective response rate in ICI-refractory ESCC. Eligible patients will receive QL1706 (5 mg/kg IV Q3W) and celecoxib (200 mg BID orally) until disease progression, unacceptable toxicity, or up to 2 years. Safety, PFS, OS, and biomarkers such as PD-L1, HER2, IL-6, and IL-8 will also be evaluated.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	QL1706 Plus Celecoxib Group	QL1706 (anti-PD-1/CTLA-4 bispecific antibody) will be administered at 5 mg/kg by intravenous infusion every 3 weeks. Celecoxib 200 mg will be taken orally twice daily starting on Day 1 of each 3-week treatment cycle. Treatment continues until disease progression, intolerable toxicity, or for a maximum of 2 years.

Timeline

• Start date: 2025-07-15
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2025-07-03
• Last updated: 2025-07-03