To evaluate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of esophageal small cell carcinoma
1. Sign a written informed consent to join the study voluntarily;
2. Histologically or cytologically confirmed patients with small cell carcinoma of the esophagus staging T1N0M0 but unable to tolerate surgery or refusing surgery and patients staging T2-4N0-3M0 [according to AJCC 8th edition TNM criteria];
3. Age 18-75 years old, male or female;
4. ECOG PS 0-1;
1. Esophageal perforation or hematemesis;
2. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;
3. Uncontrolled hypercalcemia or symptomatic hypercalcemia;
4. Other malignancies diagnosed within 5 years prior to the first use of the investigational drug, except malignancies with a low risk of metastasis or death (5-year survival > 90%), such as adequately treated skin basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ, may be considered for inclusion;
Single group
Etoposide
Drug100mg/m\^2, intravenous infusion for 1-3 days,21 days/cycle, 4 cycles
Cisplatin
Drug25mg/m\^2 ,intravenous infusion for 1-3 days ,21 days/cycle, 4 cycles
Carboplatin
DrugCarboplatin (AUC = 5) on 1 Day,21 days/cycle, 4 cycles ;
Adebrelimab
Drug1200mg adebrelimab was given intravenously on 2 day after chemotherapy,21 days/cycle, continuous use.
radiotherapy
RadiationStage I-IVa , prescription dose: PTV 50Gy/25f. Stage IVb ,prescribed dose: PTV 30Gy/10f.
Objective response rate (ORR)
Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation.
Disease control rate (DCR)
Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR), partial remission (PR), and stable disease (SD) as rated according to RECIST 1.1 criteria.
Progression-free survival (PFS)
PFS was defined as the date from which the subject was first given medication to the date when tumor progression (as assessed by the criteria, with or without continued treatment) was first recorded or the date of death from any cause, whichever came first.
Overall survival (OS)
Defined as the time between the date of first dose and the death of the subject due to all causes. Subjects who were alive at the last follow-up visit had OS counted as data censored at the time of the last follow-up visit. The OS of subjects who were lost to follow-up was counted as data censored at the time of last confirmed survival prior to the lost follow-up. OS for data censoring was defined as the time from first dose to censoring.
One-Year Overall Survival Rate
It refers to the probability that a patient will survive one year after receiving treatment.
Explore potential biomarkers in tumor tissue
ORR corresponding to PD-L1 negative expression, positive expression (TPS≥1%), low expression (\<10%), high expression (TPS\>50%)
Explore potential biomarkers in the Peripheral Blood of Cancer Patients
ORR corresponding to the absolute lymphocyte count and specific T lymphocyte count in the peripheral blood of patients, as well as the composition of oxidized lipid species.
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