drugset / Trial / NCT07699185

Neoadjuvant Cardonilizumab Combined With Neoadjuvant Chemoradiotherapy Can Resect Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07699185

Phase 2 Recruiting 336 enrolled Tongji Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications

Timeline

Start
2024-01-29
Primary completion
2026-07-01
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cardonilizumab Unknown 10 mg/kg Intravenous
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 135 mg/m2 Intravenous