Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line ESCC.

Who may be able to join

• 1. Age 18-75 years old, male or female; 2. Esophageal squamous cell carcinoma confirmed by histology or cytology; 3. Patients who have progressed or are intolerant to first-line chemotherapy combined with immunotherapy (chemotherapy regimen can include platinum, purple shirt or fluorouracil as the basis, etc.) (progression of maintenance therapy after first-line chemotherapy combined with immunization can also be included).
• 4. Cohort A: Subjects who have at least one of the following two conditions will be treated with adebelimab combined with apatinib mesylate and chemoradiotherapy;
• Symptomatic dysphagia, Mellow score ≥1 (Mellow score: 0 = able to eat all solid foods, 1 = only partially solid foods, 2 = able to eat soft foods, 3 = only able to drink liquids, 4 = complete dysphagia);
• Hypometastatic disease: Oligometastatic disease is considered when there are ≤ 3 metastases in the liver, lungs, retroperitoneal lymph nodes, adrenal glands, soft tissues, bones, or brain. In addition, after receiving a median of 18 weeks of systemic therapy, metastatic lesions are considered to be oligometastatic lesions at the time of restaging if they do not progress or only progress in size. If the number of lesions increases when restaged after systemic therapy, it is not considered oligometastatic disease.
• Cohort B: If the subjects do not have the above conditions, they will be treated with adebelimab in combination with apatinib mesylate and chemotherapy; 5. Have at least one measurable lesion according to the Efficacy Evaluation Criteria in Solid Tumors (RECIST 1.1); 6.ECOG：0～1； 7. Expected survival≥12 weeks; 8. The blood routine and biochemical indexes of the subjects within 7 days before enrollment meet the following criteria:
• Hemoglobin ≥90g/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L (patients must not have received blood transfusion or growth factor support within 14 days of blood sample collection); b. ALT, AST ≤ 2.5 times the upper limit of normal (ULN); ALP ≤ 2.5 times ULN; c. Serum total bilirubin < 1.5 times ULN (patients with Gilbert syndrome can be enrolled if total bilirubin < 3 times ULN); d. Serum creatinine < 1.5 times ULN or estimated glomerular filtration rate ≥60ml/min/1.73m2; e. Serum albumin≥30g/L; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the range of anticoagulant intended treatment; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).
• 10. Females of childbearing potential should agree to use contraception (such as intrauterine device, contraceptive pills or condoms) during the study and for 6 months after the end of the study, have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients, and males should agree to use contraception during the study and for 6 months after the end of the study period; 11. No serious concomitant disease that makes the survival time < 5 years; 12. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.