A Phase 1/2 interventional study of Camrelizumab in Esophageal Neoplasm, Immunotherapy and Radiotherapy, sponsored by Fujian Medical University Union Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Fujian Medical University Union Hospital · Phase 1/2, Interventional, and Treatment
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 25 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate organ function, subjects need to meet the following laboratory indices:
Exclusion Criteria:
is receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study.
Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted.
Presence of any serious or uncontrollable systemic disease, such as
Drug: Camrelizumab
Neoadjuvant Camrelizumab combined with radiotherapy
Efficacy of Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
Major pathological remission rate
Time frame: 2 week after operation
Safety of Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
Number and percentage of cases of all adverse events
Time frame: 2 week after operation
Efficacy of Camrelizumab in Combination With Radiotherapy for Neoadjuvant
Complete pathology remission rate
Time frame: 2 week after operation
Plan to share: Undecided
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Fujian Medical University Union Hospital