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RECRUITING
NCT06122493
PHASE2

Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2022-11-01

Completion Date

2026-11-01

Last Updated

2023-11-08

Healthy Volunteers

No

Interventions

DRUG

Tirelizumab

immunotherapy, 200 mg on day 1 per 3 weeks

DRUG

Nab paclitaxel

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

DRUG

Carboplatin

chemotherapy, AUC=5 on day 1 per 3 weeks

RADIATION

Radiotherapy

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