Esophageal Squamous Cell Cancer
Conditions
Interventions
Intervention group:adebrelimab combined with chemotherapy
Sponsors
National Cancer Center/Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study and signed informed consent; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma;3. Clinical stage T1N+ or T2-4a, N any; 4. Subjects expected to have R0 resection; 5. Subjects voluntarily to have esophagus preservation; 6. Male and female patients aged at least 18 years; 7. Eastern cooperative oncology group (ECOG) performance status of 0 to 1;8. No prior treatment for this disease; 9. Subjects had no major organ dysfunction; 10. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug; 11. Patients are expected to have good compliance and be able to follow up.
Exclusion criteria
Exclusion criteria: 1. Bad nutrition, BMI < 17.5 Kg/m2; 2. Allergic history to any drug in this trial; 3. Treated with immunosuppressive drugs within 2 weeks prior to the first dose, live attenuated vaccine injection within 4 weeks prior to the first dose, major surgery or significant trauma within 4 weeks prior to the first dose; 4.Have any active autoimmune disease or history of autoimmune disease; 5. Suffering from congenital or acquired immune deficiency; 6. Have an uncontrolled cardiac clinical condition or disease; 7. Complicated severe infection within 4 weeks prior to first dose; 8.Patients with active tuberculosis infection; 9. Patients with active HBV or HCV; 10. Other malignancies diagnosed within 5 years prior to first administration of study drug;11. Pregnant or breastfeeding women; 12. Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete response (cCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Two-year progression free survival;Three-year progression free survival;Two-year overall survival;Three-year overall survival;Esophagus preservation rate; | — |
Countries
China
Contacts
Public ContactJing Huang
National Cancer Center/Chinese Academy of Medical Sciences
Outcome results
None listed