RecruitingPhase 2NCT06122493

Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma

Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma: a Phase Ⅱ Single Arm Prospective Study


Sponsor

Ruijin Hospital

Enrollment

48 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy. The approach entails combining chemotherapy with immune therapy, followed by synchronized radiotherapy during the immune maintenance phase. The primary goal is to mitigate treatment-related side effects and enhance the overall prognosis through the integration of these treatment modalities.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for the best treatment approach for people with esophageal squamous cell cancer (a type of cancer in the food pipe) that has spread to many nearby lymph nodes (called cN3 disease) and cannot be removed with surgery. It compares different combinations of chemotherapy, radiation, and immunotherapy. **You may be eligible if...** - You have confirmed squamous cell esophageal cancer - Your cancer has spread to many nearby lymph nodes but not to distant organs (any T, N3, M0) - You have not had prior chest radiation or chemotherapy for this cancer - You are in reasonable overall health (ECOG 0–2) with a life expectancy of at least 6 months **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have a history of other active cancers (except treated skin cancers) - You have active HIV, active hepatitis B or C, or syphilis - You are pregnant or breastfeeding - You have severe heart disease or respiratory failure 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

DRUGTirelizumab

immunotherapy, 200 mg on day 1 per 3 weeks

DRUGNab paclitaxel

chemotherapy, 175 mg/m² on day 1 per 3 weeks

DRUGCarboplatin

chemotherapy, AUC=5 on day 1 per 3 weeks

RADIATIONRadiotherapy

Patients without disease progression after four cycles of chemoimmunotherapy receive radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy delivered over 28 fractions.


Locations(1)

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, China

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NCT06122493


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