| Eligibility |
Inclusion Criteria:
Subjects voluntarily participate and sign written informed consent; Age =18 years;
Confirmed by histopathology and/or cytology as esophageal squamous cell carcinoma; At least
one measurable lesion according to AJCC 8th staging and RECIST 1.1 solid tumor evaluation
criteria.
Those who have received immunocheckpoint inhibitors combined with chemotherapy (e.g.,
paclitaxel + cisplatin) in the first line, and the disease has not progressed;
Good functioning of major organs, no serious uncontrolled hypertension, diabetes and heart
disease, that is, the relevant indicators within 14 days before treatment meet the
following requirements:
- ANC=1.2×109/L and lymphocyte count =0.5×109/L without the support of granulocyte
colony stimulating factor;
- Without blood transfusion, patients with platelet count =100×109/L and hemoglobin
=90g/L can meet the criteria through blood transfusion;
- AST, ALT and ALP=2.5× upper limit of normal (ULN), total bile red =1.5×ULN, except the
following conditions: for known Gilbert patients: total bilirubin =3×ULN, creatinine
=1.5×ULN, albumin =25g/L;
- For patients not receiving anticoagulant therapy: INR and aPTT=1.5×ULN. estimated
survival =3 months; Score of ECOG physical strength: 0~1; The ability of patients to
follow the study protocol according to the judgment of the investigator.
Exclusion Criteria:
Previous immunotherapy; no measurable lesions; There are small cell carcinoma,
adenocarcinoma or mixed carcinoma components in the histology; Complete esophageal
obstruction; Any NCI CTCAE= Grade 2 toxicity that has not recovered after previous
chemotherapy; High risk of esophageal fistula was found through clinical evaluation or
imaging examination, such as history of esophageal fistula or related symptoms, or primary
tumor infiltration into large blood vessels or trachea; had positive detection for EB virus
(EBV) capsid antigen IgM during screening (PCR method); If a patient requires analgesic
treatment, the treatment regimen used at the time of enrollment must be stable; The men who
have HIV positive results at the time of screening; people who test positive for hepatitis
C virus (HCV) during sieving; HBV positive screening, and cccDNA=500 IU/mL; Any of the
following diseases in the 12 months prior to enrollment: myocardial infarction,
severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive
heart failure, or cerebrovascular accident; Pregnant or lactating women or fertile but did
not take contraceptive measures; suffer any other serious physical or mental problem of an
acute or chronic nature; judging by the researchers, that doesn't fit to participate in the
study.
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