Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
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.