| Eligibility |
Inclusion Criteria:
1. Age: 18-75 years old, male or female;
2. Esophageal squamous cell carcinoma was confirmed by pathology (except for cervical and
Suprathoracic tumors that could not be operated);
3. Patients with resectable esophageal squamous cell carcinoma with clinical stage T3-T4a
or TxN + M0 (except T4b);
4. ECOG PS score was 0-1;
5. There was at least one measurable lesion (according to recist1.1) or unmeasurable
lesion that could be evaluated, and the imaging diagnosis time was = 21 days;
6. The expected survival time was more than 3 months;
7. The function of the main organs was normal, and there were no serious blood, heart,
lung, liver, kidney, bone marrow and other functional abnormalities and
immunodeficiency diseases. The laboratory examination meets the following
requirements:
1. Hemoglobin (Hb) = 90g / L;
2. WBC = 3.0 × 109/L; Neutrophil count (NEUT) = 1.5 × 109/L;
3. Platelet count (PLT) = 100 × 109/L;
4. Serum creatinine (SCr) = 1.5 times the upper limit of normal (ULN) or creatinine
clearance rate = 50 ml / min (Cockcroft Gault formula);
5. Total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN);
6. The levels of AST and ALT were less than 2.5 times the upper limit of normal
(ULN);
8. There was no active bleeding or thrombosis
1. International normalized ratio INR = 1.5 × ULN;
2. Partial thromboplastin time APTT = 1.5 × ULN;
3. Prothrombin time Pt = 1.5ULN;
9. The patients with normal or mild to moderate abnormal lung function (VC% > 60%, FEV1 >
1.2L, FEV1% > 40%, DLco> 40%) could tolerate esophagectomy;
10. The fertile female subjects were required to conduct blood pregnancy test within 72
hours before the first administration, and the result was negative, and voluntarily
used appropriate contraceptive methods during the observation period and within 90
days after the last administration of the study drug; For men, surgical sterilization
or consent to appropriate contraceptive methods during the observation period and
within 90 days after the last administration of the study drug should be used.
11. The subjects voluntarily joined the study and signed the informed consent form (ICF);
12. The patients with good compliance were expected to follow up the efficacy and adverse
events / reactions according to the protocol requirements.
Exclusion Criteria:
1. Subjects who have received or are receiving additional chemotherapy, radiotherapy,
targeted or immunotherapy;
2. Any active autoimmune disease or history of autoimmune disease (such as interstitial
pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis,
nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement
therapy)); The subjects with childhood asthma who had been completely relieved and did
not need any intervention or vitiligo in adulthood could be included, but the subjects
who needed bronchodilator for medical intervention could not be included;
3. Patients with congenital or acquired immune deficiency, such as human immunodeficiency
virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU / ml), hepatitis C (HCV
antibody positive and HCV-RNA higher than the detection limit of the analytical
method), or co infection of hepatitis B and hepatitis C;
4. Immunosuppressive drugs were used within 14 days before the first use of the study
drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic
corticosteroids;
5. Live attenuated vaccine was inoculated within 4 weeks before the first administration
or during the study period;
6. Patients with hypertension who can not be reduced to normal range after
antihypertensive drug treatment (systolic blood pressure = 140 mmHg / diastolic blood
pressure = 90 mmHg);
7. Subjects with uncontrollable clinical cardiac symptoms or diseases, such as (1) heart
failure of NYHA II or above (2) unstable angina pectoris (3) myocardial infarction
within 1 year (4) clinically significant supraventricular or ventricular arrhythmia
requiring clinical intervention;
8. Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral
drugs) occurred within 4 weeks before the first administration, or fever of unknown
origin > 38.5% occurred during the screening period / before the first administration;
9. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell
transplantation is known;
10. Pregnant or lactating women; The fertile subjects were unwilling or unable to take
effective contraceptive measures;
11. Other malignant tumors were found in the past or at the same time, but the cured basal
cell carcinoma of skin, carcinoma in situ of cervix and carcinoma in situ of breast
were excluded;
12. Known to have allergic history to the drug components of this protocol;
13. Other situations considered unsuitable by the researchers.
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