drugset / Trial / NCT05355168

Neoadjuvant CRT Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Esophageal Carcinoma

NCT05355168

Phase 2 Completed 35 enrolled Anhui Provincial Hospital
NaSingle-groupOpen-labelTreatment

Summary

Neoadjuvant chemoradiotherapy followed by surgery has been the standard modality for locally advance esophageal carcinoma. According to CROSS study, the pathological complete remission rate achieved by paclitaxel and carboplatin with 41.4 Gy/23f was 49% for esophageal squamous cell carcinoma. But the 10-year overall survival rate was only 38%. How to increase the overall survival of esophageal carcinoma is a pivotal task. Both of Camrelizumab and Nimotuzumab have been demonstrated to be efficacious in the neoadjuvant treatment for esophageal squamous cell carcinoma in some small sample-size trials. Therefore, this trial is designed to combine adjuvant chemoradiotherapy with Camrelizumab and Nimotuzumab for resectable \& potentially resectable locally advanced esophageal squamous cell carcinoma and explore the safety and primary efficacy of such combination.

Timeline

Start
2021-11-01
Primary completion
2023-12-31
Completion
2024-03-31

Drugs

EvaluationDrugModalityDoseRoute
Background Camrelizumab Monoclonal antibody 200 mg
Background Carboplatin Small molecule
Background Nimotuzumab Monoclonal antibody 200 mg
Background Paclitaxel Small molecule 50 mg/m2

Indications