NCT07038629

Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC

Concurrent Chemoradiation Plus Iparomlimab Consolidation Therapy for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-arm Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 70 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma (ESCC). Aim to evaluate the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiation with S-1 in elderly patients with unresectable locally advanced ESCC. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. However, the overall prognosis of patients still needs to be further improved. The emergence of immune checkpoint inhibitors has brought new hope for patients with ESCC. Iparomlimab can target both PD-1 and CTLA-4 immune inhibitory pathways simultaneously. Studies have shown that it can significantly improve the prognosis in the treatment of ESCC and has good tolerability. In elderly patients with ESCC, concurrent chemoradiation may potentially carry the risk of low treatment completion rate and significant toxicity. Therefore, this study aims to explore the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiotherapy in elderly patients with unresectable locally advanced ESCC. In the study, the investigators plan to enroll 52 elderly subjects with locally advanced ESCC. After receiving radiotherapy combined with the S-1 regimen, patients will enter the screening period. The enrolled patients will receive Iparomlimab consolidation therapy for 1 year. The treatment efficacy and safety will be evaluated.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	S1	PO, 40\~60mg，BID（d1-14，d22-35，two cycles)
DRUG	Iparomlimab	IV infusion, 5mg/kg, q3w (Started within 8 weeks of completion of radiation)
RADIATION	Radiation	Concurrent Radiation, 1.8Gy/f, 28f;

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-09-30
• Completion: 2027-09-30
• First posted: 2025-06-26
• Last updated: 2026-01-07

Locations

1 site across 1 country: China