RecruitingPhase 2NCT06709417

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)


Sponsor

Shanghai Chest Hospital

Enrollment

52 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of sintilimab combined with chemotherapy, followed by sequential concurrent chemoradiotherapy as conversion therapy, in treatment-naïve esophageal squamous cell carcinoma (ESCC) patients with cT4bN-/+M0 and/or cTanyN+M0 staging (including those with extracapsular invasion of mediastinal lymph nodes).


Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug sintilimab (a PD-1 inhibitor) to standard chemotherapy before and during radiation therapy improves outcomes in people with locally advanced, inoperable esophageal squamous cell cancer. **You may be eligible if...** - You are between 20 and 75 years old - You have confirmed esophageal squamous cell carcinoma in the chest that cannot be removed by surgery - Your cancer has not spread to distant organs - You have not received any prior treatment for esophageal cancer - You are in good physical condition (ECOG 0-1) with life expectancy of at least 6 months - You have at least one measurable tumor **You may NOT be eligible if...** - You have received prior chemotherapy, radiation, or immunotherapy for esophageal cancer - Your cancer has spread to distant organs - You have conditions that make immunotherapy or chemotherapy unsafe 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

DRUGSintilimab

Sintilimab 200mg iv Q3W

DRUGChemotherapy

Liposomal paclitaxel: 150mg/m2, Q3W + cisplatin: 75mg/m2, Q3W (combined with PD-1 therapy) Liposomal paclitaxel: 50mg/m2, Q3W + cisplatin: 20mg/m2, Q3W (combined with radiotherapy )

RADIATIONradiotherapy

The total dose is 5040cCy in 28 fractions (5 days per week, 1.8 Gy/day).


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06709417


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