esophageal squamous carcinoma
Conditions
Interventions
treatment group: adebrelimab+Chidamide+S-1
Sponsors
First affiliated hospital of Soochow university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: a. Pathological diagnosis of metastatic esophageal squamous cell carcinoma; b. Age = 18, gender unlimited; c. The Eastern Cancer Collaboration Group (ECOG) physical status score was 0 or 1; d. Life expectancy of more than 3 months; e. According to RECIST 1.1 criteria, the patient had at least one target lesion with a measurable diameter (tumor lesion with a CT scan diameter =10 mm, lymph node lesion with a CT scan diameter =15 mm, and scan layer thickness no more than 5 mm); f. Previous PD-1 monoclonal antibody monotherapy or combined standard chemotherapy treatment; g. Good function of major organs: good hematopoietic function, defined as neutrophil absolute count =1.5×10^9/L, platelet count =100×10^9/L, hemoglobin =90g/L; Good liver function, defined as total bilirubin level = the upper limit of normal (ULN); Patients without liver metastasis had good liver function, defined as total bilirubin level = the upper limit of normal (ULN); In patients without liver metastasis, the levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were =1.5 times ULN, alkaline phosphatase =2.5 times ULN, and in patients with recorded liver metastasis, AST and ALT levels were =5 times ULN. Good renal function, defined as serum creatinine =1.5 times ULN or calculated creatinine clearance = 60ml/min (Cockcroft-Gault formula); Urine protein is less than 2+ for routine urine examination. If the patient has urine protein =2+ at baseline level, 24-hour urine should be collected and 24-hour urine protein quantitative detection =1g should be demonstrated. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN; h. Willing and able to comply with study plan visits, treatment plans, laboratory tests and other study procedures; i. For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first study drug administration (cycle 1, day 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. If there is a risk of conception, male and female patients should use highly effective contraception (i.e. a method with a failure rate of less than 1% per year) for at least 180 days after stopping the trial treatment.
Exclusion criteria
Exclusion criteria: a. Histologically non-esophageal squamous cell carcinoma components; b. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices in the week prior to initial dosing; c. Allergic to any component of the investigational drug; d. Non-surgical sterilized or fertile female patients must have a negative serum HCG test within 72 hours prior to their first medication, must be non-lactating, and must consent to the use of appropriate contraceptive methods (such as Iuds, contraceptives, or condoms) during the study treatment period and for 3 months after the end of the study treatment period; The male patient agrees to use an appropriate method of contraception during the study treatment period and for 3 months after the end of the study treatment period; e. Active brain metastases; Patients with asymptomatic brain metastases could be enrolled. For patients with clinically suspected CNS metastasis, CT or MRI examination must be performed within 28 days before enrollment to rule out CNS metastasis. f. Patients with a history of unstable angina; Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening; Arrhythmias (including QTcF: =450ms in men and =470ms in women) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade =II cardiac insufficiency; g. Urine routine indicated urinary protein =++ and confirmed 24-hour urinary protein quantity > 1.0g; h. Have a 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 above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C; Or have a history of organ transplantation; i. Patients with hypersensitivity to human or murine monoclonal antibodies; j. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; k. pleural effusion or abdominal effusion with clinical symptoms requiring clinical intervention; l. A concomitant disease that, in the judgment of the investigator, seriously endangers the patient's safety or interferes with the patient's completion of the study; m. Other conditions that the investigator determined were not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progressives free survival;overall survival;6 months progression free survival rate;6 months overall survival rate;12 months progression free survival rate;12 months overall survival rate;disease control rate;quality of life; | — |
Countries
China
Contacts
Public ContactWei Li
First Affiliated Hospital of Soochow University
Outcome results
None listed