NCT06510660

Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC

Adebrelimab with or Without Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Phase 2 Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma

Detailed description

This is a prospective, two-cohort, multicenter clinical study. Subjects received different treatments based on their CPS scores. During induction therapy, subjects in cohort 1 (CPS score ≥10) received adebrelimab, while cohort 2 (CPS score \< 10) were administered adebrelizumab + carboplatin/cisplatin + paclitaxel/nab-paclitaxel. Both groups received carboplatin/cisplatin + paclitaxel/nab-paclitaxel combined radiotherapy during concurrent chemoradiotherapy. The primary endpoint was cCR rate.

Conditions

• Esophageal Squamous Cell Carcinoma
• Immunotherapy
• Biomarkers

Interventions

Type	Name	Description
DRUG	adebrelimab	The study was divided into two cohorts based on CPS score, with those with CPS scores ≥10 receiving induction therapy with adebrelimab alone and those with CPS scores \<10 receiving induction therapy with adebrelimab in combination with chemotherapy. At the end of the induction period, concurrent radiotherapy treatment was administered

Timeline

• Start date: 2024-04-11
• Primary completion: 2025-12-01
• Completion: 2028-12-01
• First posted: 2024-07-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China