| Eligibility |
Inclusion Criteria:
1. Histology confirmed as esophageal squamous cell carcinoma;
2. The clinical stages are cT1b-T4aN0M0, cT1-T4aN+M0;
3. The subjects were required to complete preoperative concurrent chemoradiotherapy and
complete R0 resection before enrollment;
4. The shortest time of neoadjuvant therapy was 6 weeks and the longest was 12 weeks;
5. Postoperative pathology: T1 or above T1, N1 or N1 above, no distant metastasis;
6. Aged 18-75;
7. ECOG:0-1;
8. The main organs function normally, that is, the following criteria are met:
Blood routine examination:
HB=90g/L; ANC = 1.5 × 109 / L; PLT = 80 × 109 / L;
Biochemical examination:
ALB = 30g / L;b.ALT and AST = 2.5ULN; if there is liver metastasis, ALT and AST =
5ULN;c.TBIL = 1.5ULN;d.plasma Cr = 1.5ULN or creatinine clearance (CCr) = 60ml / min;
9. There was no serious concomitant disease with a survival time of less than 5 years;
10. Voluntary and able to comply with the protocol during the study;
11. Provide written informed consent before entering the study, and patients have
understood that they can withdraw from the study at any time without any loss.
Exclusion Criteria:
1. Patients with previous or concurrent malignant tumors, except for skin basal cell
carcinoma and cervical carcinoma in situ that have been cured; patients with small
gastric stromal tumor and other tumors, which are judged by researchers to have no
impact on the patient's life in the short term, can be excluded;
2. Participated in other drug clinical trials within four weeks;
3. The patient has any active autoimmune disease or a history of autoimmune disease (such
as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia,
uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,
nephritis,Hyperthyroidism; patients with vitiligo ; Asthma has been completely
relieved in childhood, and patients who do not need any intervention after adulthood
can be included; asthma patients who require bronchodilators for medical intervention
cannot be included);
4. The patient is using immunosuppressive agents or systemic hormonal therapy for
immunosuppressive purposes (dose> 10 mg/day of prednisone or other therapeutic
hormones) and continues to be used for 2 weeks prior to enrollment;
5. Any active malignant tumor within 2 years, except for the specific cancer under study
in this study and locally recurrent cancer that has been cured (such as resected basal
cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast
cancer in situ);
6. Patients with known history of CNS metastasis or CNS metastasis before screening. For
patients with clinically suspected CNS metastasis, CT or MRI must be performed within
28 days before randomization to exclude CNS metastasis;
7. Patients with unstable angina pectoris history, newly diagnosed angina pectoris within
3 months before screening or myocardial infarction events occurred within 6 months
before screening; arrhythmias (including QTCF: male = 450 ms, female = 470 MS) need
long-term use of antiarrhythmic drugs and NYHA grade = II cardiac insufficiency;
8. Urine routine examination showed that urinary protein was = + +, and 24-hour urinary
protein was more than 1.0 G;
9. For female subjects: they should be surgical sterilization, postmenopausal patients,
or agree to use a medically approved contraceptive method during the study treatment
period and within 6 months after the end of the study treatment period; the serum or
urine pregnancy test must be negative within 7 days before the study enrollment, and
must be non lactation period. Male subjects: they should be surgical sterilization or
agree to use a medically approved contraceptive method during the study treatment
period and within 6 months after the end of the study treatment period;
10. The patient had received liver transplantation;
11. Patients with infectious pneumonia, non infectious pneumonia, interstitial pneumonia
and other patients who need to use corticosteroids;
12. Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus,
etc;
13. Patients had a history of inflammatory bowel disease such as ulcerative enteritis and
Crohn's disease, and a history of chronic diarrhea such as irritable bowel syndrome;
14. Patients with a history of sarcoidosis or tuberculosis;
15. Patients with a history of active hepatitis B and hepatitis C and HIV infected
patients;
16. Patients with a history of psychotropic substance abuse and can't quit or have mental
disorders;
17. Pleural effusion or ascites with clinical symptoms and requiring clinical
intervention;
18. Patients with a history of immunodeficiency, or other acquired or congenital
immunodeficiency diseases, or a history of organ transplantation;
19. According to the judgment of the researchers, there are accompanying diseases that
seriously endanger the safety of patients or affect patients to complete the study.
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