NCT06654297

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Palbociclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab will be given at at a dose of 200 mg intravenously on day 23 of a planned 28-day cycle, and two doses before surgery.
DRUG	Palbociclib(100mg)	Palbociclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for three cycles.
DRUG	Palbociclib(125mg)	Palbociclib will be given at a dose of 125 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for three cycles.

Timeline

• Start date: 2024-10-27
• Primary completion: 2025-06-03
• Completion: 2027-02-07
• First posted: 2024-10-23
• Last updated: 2026-04-02

Locations

1 site across 1 country: China