NCT06663059

Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study

A Prospective, Multicenter, Exploratory Study Comparing 2 Cycles Versus 4 Cycles of Adebrelimab Combined With Chemotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.

Detailed description

This study is a prospective, multicenter, exploratory clinical trial. It involves patients with resectable locally advanced thoracic esophageal squamous cell carcinoma confirmed by histopathology or cytology. The study aims to compare the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for these patients. Eligible patients will be randomly assigned in a 1:1 ratio to either the 2-cycle group or the 4-cycle group. The primary endpoint is pathological complete response (pCR), with a planned enrollment of 80 patients. The study consists of a screening period (from the signing of the informed consent form to the first administration of the drug, not exceeding 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (including safety follow-up, tumor progression/recurrence follow-up, and survival follow-up).

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle	Each treatment cycle is 3 weeks long (Q3W), with a total of 2 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.
DRUG	Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle	Each treatment cycle is 3 weeks long (Q3W), with a total of 4 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-01
• Completion: 2027-09-01
• First posted: 2024-10-29
• Last updated: 2024-10-29

Locations

1 site across 1 country: China