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This is an investigator-initiated, single-arm, single-center, exploratory clinical study.The study population consisted of patients with R0 resection of esophageal squamous cell carcinoma who had not received radiation therapy.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with radiotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.About 20 subjects are planned to be enrolled in this study.Drug regimen: Patients with esophageal squamous cell carcinoma received radiotherapy combined with carrilizumab adjuvant therapy for 6 cycles 1-3 months after R0 resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | The adjuvant treatment of radiotherapy combined with carrilizumab lasted for 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | PD-1antibodies,200mg ivgtt Q3W |
| |
| radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year disease-free survival rate (1-year DFS) | The percentage of subjects who were free of disease recurrence or death from the start of study enrolment to 12 months later. | up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment. | up to approximately 2 year |
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Inclusion Criteria:
Age 18 - 75 year,male or female;
The clinical stages of esophageal squamous cell carcinoma diagnosed by pathology (including histology or cytology) were T1-4AN0M0 and T1-4AN +M0
Patients who underwent surgical resection and were assessed as R0.However, patients who have received previous radiotherapy should be excluded
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Survival expectation ≥ 3 months;
The laboratory test value of the patient before medication should meet the following standards:
Women of childbearing age must have a serum pregnancy study within 2 weeks prior to the first dose and the results are negative. Female subjects of childbearing age and partners who are women of childbearing age must be contraceptive during the study period and within 180 days after the last administration of the study drug;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhichao Fu, Prof | Contact | 13774562945 | fauster1112@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital | Recruiting | Fuzhou | Fujian | 350025 | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiation |
45-55Gy/1.8~2.0Gy |
|
| Disease-free survival (DFS) | The time from enrolment (ICF signing) to disease recurrence or death due to disease progression. | up to approximately 2 year |
| Overall survival (OS) | the time between subjects' death from various causes.For subjects still alive at the last follow-up, their OS was measured as data deletion by the time of the last follow-up. | up to approximately 3 year |