NCT07263919

Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)

A Randomized, Controlled, Multi-center Phase II/III Clinical Trial of Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma (ESCC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, multi-center phase II/III study. All patients are resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of perioperative Cadonilimab combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in patients with resectable ESCC.

Conditions

• Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab (AK104)	Specified doses on specified days.
DRUG	Cisplatin	IV infusion; 75mg/m2
DRUG	Paclitaxel	IV infusion; 175mg/m2

Timeline

• Start date: 2025-12-19
• Primary completion: 2030-03-01
• Completion: 2031-12-01
• First posted: 2025-12-04
• Last updated: 2025-12-31

Locations

1 site across 1 country: China