RecruitingPhase 2NCT07038629

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

52 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 70 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug called iparomlimab after chemoradiation treatment improves outcomes in older patients (aged 70+) with locally advanced esophageal squamous cell carcinoma (a type of throat/food-pipe cancer). **You may be eligible if...** - You are 70 years old or older - You have locally advanced esophageal squamous cell cancer confirmed by biopsy - You have not yet received treatment for this cancer - You are willing to complete follow-up visits **You may NOT be eligible if...** - Your cancer has spread to distant organs beyond the allowed extent - You have serious autoimmune diseases or are on immune-suppressing medications - Your heart or lung function is too poor to tolerate combined treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGS1

PO, 40\~60mg,BID(d1-14,d22-35,two cycles)

DRUGIparomlimab

IV infusion, 5mg/kg, q3w (Started within 8 weeks of completion of radiation)

RADIATIONRadiation

Concurrent Radiation, 1.8Gy/f, 28f;


Locations(1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

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NCT07038629


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