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Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.

Immunotherapy Clinical Trial

Official title:
The Safety and Efficacy of Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Squamous Cell Carcinoma.

Clinical Trial Summary

This is an exploratory phase II clinical study designed to evaluate the safety and efficacy of Camrelizumab in combination with standard radiotherapy as preoperative neoadjuvant therapy for patients with resectable esophageal squamous cell carcinoma. In the study, all subjects who met the enrollment criteria are enrolled after giving full informed consent and signing the enrollment informed consent form, and received radical surgery within 4-8 weeks after completion of neoadjuvant Camrelizumab in combination with standard radiotherapy. The safety evaluation indicators for the study were so adverse events and the number and proportion of subjects who discontinued treatment due to adverse events. The main efficacy indicators of the study were the rate of major pathological remission and the rate of complete pathological remission. A total of 26 cases had to be enrolled in the study. Phase I enrollment was 12 cases, with at least 5 cases achieving efficacy to proceed to Phase II. The trial was considered successful when 14 cases were enrolled in the second phase and the total number of effective cases was greater than 13. The need for postoperative adjuvant treatment and the adjuvant treatment plan were determined by the investigator, and all subjects were required to complete the study's follow-up plan after surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05176002
Study type Interventional
Source Fujian Medical University Union Hospital
Contact Chun Chen, Dortor
Phone 15959002753
Email lacustrian@163.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 23, 2021
Completion date September 2024
View Details
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