drugset / Trial / NCT06356688

A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT06356688 ↗

Phase 2 Recruiting 30 enrolled Sun Jing
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.

Timeline

Start
2025-04-20
Primary completion
2027-06-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody 10 mg/kg Intravenous
Subject Cisplatin Other / unclassified 25 mg/m2 Intravenous
Subject Paclitaxel Small molecule 230 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous