NCT06161909

Postoperative Immune Maintenance Therapy for Esophageal Squamous Cell Carcinoma After Radical Resection

Postoperative Adjuvant Immune Maintenance Therapy for High Recurrence Risk Esophageal Squamous Cell Carcinoma After Radical Resection: a Multicenter Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Esophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma. And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma (ESCC), postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible. The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy.

Detailed description

sophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma. And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma (ESCC), postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible. The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy. All participants who meet the inclusion criteria will be enrolled after signing the informed consent form. A total of 400 patients are to be recruited for the study. 400 subjects were randomly assigned to the two treatment groups. Group A: Postoperative adjuvant sintilimab 200mg fixed dose Q3W, immunotherapy will be administered for a total of 1 year. Group B: Close observation. The primary endpoint is disease-free survival (DFS). The secondary endpoints are postoperative overall survival (OS); 1, 2, and 3-year postoperative OS rates; recurrent metastasis pattern (local recurrence or distant metastasis).

Conditions

• Esophageal Squamous Cell Carcinoma Thoracic Stage II
• Esophageal Squamous Cell Carcinoma Thoracic Stage III
• Esophageal Squamous Cell Carcinoma Thoracic Stage IV

Interventions

Type	Name	Description
DRUG	sintilimab	200mg fixed dose Q3W,1 year

Timeline

• Start date: 2024-01-10
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2023-12-08
• Last updated: 2023-12-08

Locations

1 site across 1 country: China