Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05176002
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
Sponsor:
Fujian Medical University Union Hospital
Organization:
Study Overview
Official Title:
The Safety and Efficacy of Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Squamous Cell Carcinoma.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eligible subjects who meet the inclusion criteria will be enrolled after providing full informed consent and signing the informed consent form. All enrolled patients will undergo radical surgery within 4-8 weeks after completion of neoadjuvant Camrelizumab combined with standard radiotherapy.
The safety evaluation indicators include the incidence of adverse events and the number and proportion of subjects who discontinue treatment due to adverse events. The primary efficacy endpoints are the major pathological response rate and the pathological complete response rate. Based on previous studies, the expected response rate is 40% in the experimental group and 20% in the control group. Using a one-sided alpha level of 0.1 and a beta of 0.2, the calculated total sample size for the single-arm design is 25 patients, with 12 enrolled in the first stage. If 2 or fewer responders are observed in the first stage, the study will be terminated early for futility. If more than 2 responders are observed, the trial will proceed to the second stage. Upon completion of the second stage, if the total number of responders exceeds 7, the treatment will be considered effective. The need for postoperative adjuvant treatment and the specific adjuvant regimen will be determined by the investigator. All subjects are required to complete the postoperative follow-up plan as specified in the study protocol.
The safety evaluation indicators include the incidence of adverse events and the number and proportion of subjects who discontinue treatment due to adverse events. The primary efficacy endpoints are the major pathological response rate and the pathological complete response rate. Based on previous studies, the expected response rate is 40% in the experimental group and 20% in the control group. Using a one-sided alpha level of 0.1 and a beta of 0.2, the calculated total sample size for the single-arm design is 25 patients, with 12 enrolled in the first stage. If 2 or fewer responders are observed in the first stage, the study will be terminated early for futility. If more than 2 responders are observed, the trial will proceed to the second stage. Upon completion of the second stage, if the total number of responders exceeds 7, the treatment will be considered effective. The need for postoperative adjuvant treatment and the specific adjuvant regimen will be determined by the investigator. All subjects are required to complete the postoperative follow-up plan as specified in the study protocol.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: