Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.

Sponsor
Fujian Medical University Union Hospital
Study ID
NCT05176002
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Esophageal Neoplasm
  • Immunotherapy
  • Radiotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Neoadjuvant Camrelizumab combined with radiotherapy

Study Details

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.

Key Dates

Start date
Nov 10, 2021
Status verified
Dec 2024
Primary completion
Sep 30, 2023
Completion
Nov 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Camrelizumab combined with radiotherapy group

Primary Outcome Measure

Efficacy of Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma. [ Time Frame: 2 week after operation ]

Related Studies