NCT06122493

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible ESCC patients receive a four-cycle regimen of combined chemotherapy plus immunotherapy. Those without disease progression then get definitive radiotherapy with immune maintenance therapy for up to 12 months.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-11-08
• Last updated: 2023-11-08

Locations

1 site across 1 country: China