Esophageal squamous cell carcinoma
Conditions
Interventions
Ivarmacitinib 4 mg group:Carrelizumab 200 mg per dose, every three weeks + Ivarmacitinib 4 mg once daily
Ivarmacitinib 8 mg group:Carrelizumab 200 mg per dose, every three weeks + Ivarmacitinib 8 mg once daily
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up; 2. Age 18–75 years, inclusive of 18 and 75 years; both men and women are eligible; 3. Pathological diagnosis of esophageal squamous cell carcinoma based on biopsy; 4. Failure of first-line treatment (regardless of prior tolerance to immunotherapy); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1 (see Appendix 1 for ECOG scoring criteria); 6. =1 measurable lesion (as defined by RECIST 1.1); 7. Expected survival of >=3 months; 8. No severe abnormalities in hematopoietic, cardiac, pulmonary, hepatic, or renal function, or immunodeficiency; 9. Normal function of major organs, including (no use of any blood components, cell growth factors, granulocyte colony-stimulating factors, thrombocytopoietic agents, or anemia-correcting agents within 14 days prior to the first administration of the study drug): Neutrophils >= 1.5 × 10^9/L; Hemoglobin >= 9 g/dL; Platelets >= 100 × 10^9/L; Total bilirubin <= 1.5 times the upper limit of normal; AST (SGOT) and ALT (SGPT) <= 2.5 times the upper limit of normal; creatinine <= 1.5 times the upper limit of normal. 10. The subject voluntarily participates in this study, demonstrates good compliance, and cooperates with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Esophageal perforation or hematemesis; 2. Known hypersensitivity to macromolecular protein preparations, or to any component of camrelizumab (SHR-1316) or its formulations; 3. Uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA Class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 4. Active autoimmune disease or a history of severe immune-related adverse events (especially Grade 3 or higher), or a history of long-term immunosuppressive therapy; 5. History of high risk for thromboembolism or recent thromboembolic events; 6. Patients with congenital or acquired immunodeficiency (e.g., HIV-infected individuals), active hepatitis B (HBV-DNA >= 10^4 copies/mL) or hepatitis C (positive for HCV antibodies and HCV-RNA above the assay’s lower limit of detection), or active tuberculosis; 7. Active infection or unexplained fever >38.5°C within 2 weeks prior to randomization (fever attributed to the tumor may be acceptable for enrollment, at the investigator’s discretion); 8. Men or women of childbearing potential who are unwilling to use contraception during the trial; pregnant or breastfeeding women; 9. Other factors, as determined by the investigator, that may force the subject to discontinue the study prematurely, such as other serious illnesses (including psychiatric disorders) requiring concomitant treatment, or family or social factors that may affect the subject’s safety or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Obeject Response Rate;Disease Control Rate;Overall Surviva;Safety;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactTongpeng Xu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed