NCT06869213

A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.

Conditions

• Esophageal Cancer (EsC)

Interventions

Type	Name	Description
DRUG	Adebrelimab (SHR-1316) + Nab-paclitaxel + Cisplatin	All subjects were given 3 cycles of neoadjuvant therapy with adebrelimab (1200 mg D1, IV, Q3W)+Nab-paclitaxel(250 mg/m2 D1，IV，Q3W)+Cisplatin(75 mg/m2 D1，IV，Q3W) preoperatively. Within 4-8 weeks of completion of neoadjuvant therapy, all subjects who were suitable for surgery underwent radical surgery, and patients who underwent radical esophageal cancer with R0 resection were given adebrelimab monotherapy postoperatively until disease recurrence or metastasis, toxicity intolerance, initiation of a new antitumor therapy, subject-initiated request to withdraw from the study, and subject's judgement that the subject needed to be withdrawn from the study. The maximum duration of adebrelimab in the adjuvant phase is 16 cycles.

Timeline

• Start date: 2025-03-31
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-03-11
• Last updated: 2025-10-02

Locations

1 site across 1 country: China