NCT06888531

Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors In the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective trial design was used to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors in the treatment of locally advanced resectable esophageal squamous cell carcinoma.

Detailed description

This study is aimed at resectable thoracic esophageal squamous cell carcinoma with clinical stage T1b-2 N+ M0 or T3-4a anyN M0 (AJCC 8th). The primary endpoint of the study is pathological complete response (pCR). A total of 30 patients with locally advanced resectable esophageal squamous cell carcinoma will be enrolled in the trial after providing informed consent and passing the screening process. The treatment regimens include: Toripalimab: intravenous infusion, 240mg, D1, Q3W, for 2 consecutive doses; or Envorimab: subcutaneous injection, 400mg, D1, Q3W, for 2 consecutive doses. Albumin-bound paclitaxel: intravenous infusion, 50mg/m2, D1, QW, for 5 consecutive doses. Carboplatin: intravenous infusion, AUC=2, D1, QW, for 5 consecutive doses. Radiotherapy: 41.4Gy/1.8Gy/23F, D1-5, 5 times per week.

Conditions

• Esophageal Malignant Neoplasm Primary

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors for the treatment of locally advanced resectable esophageal squamous cell carcinoma	Toripalimab: intravenous infusion, 240mg, D1, Q3W, for 2 consecutive doses; or Envorimab: subcutaneous injection, 400mg, D1, Q3W, for 2 consecutive doses. Albumin-bound paclitaxel: intravenous infusion, 50mg/m2, D1, QW, for 5 consecutive doses. Carboplatin: intravenous infusion, AUC=2, D1, QW, for 5 consecutive doses. Radiotherapy: 41.4Gy/1.8Gy/23F, D1-5, 5 times per week.

Timeline

• Start date: 2025-03-08
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2025-03-21
• Last updated: 2025-03-21

Locations

1 site across 1 country: China