esophageal squamous cell carcinoma
Conditions
Interventions
treatment group:Preoperative treatment: SHR1316+ chemotherapy
Postoperative treatment: SHR1316
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18-75 years; 2. Histologically or cytologically confirmed, locally advanced, resectable esophageal squamous-cell carcinoma (pretreatment clinical stage cT1b-cT2, N+ or cT3-cT4a, any N according to the AJCC 8th edition); 3. Measurable and/or non-measurable lesions in Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4. ECOG 0-1; 5. The expected survival time was >= 12 weeks; 6. The main organ functions are normal; 7. Female subjects of childbearing potential, and male subjects whose partner was a woman of childbearing age, were required to use a medically approved contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) during the study treatment, for at least 3 months after the last use of SHR-1316, and for at least 6 months after the last use of chemotherapy. Women of reproductive age must have a negative blood or urine pregnancy test within 7 days before the first use of the study drug; 8. The subjects voluntarily join this study and sign the informed consent form, with good compliance and cooperation in follow-up period.
Exclusion criteria
Exclusion criteria: 1. Having received any previous antineoplastic therapy; 2.Received any study drug within 4 weeks prior to first use of the study drug; 3. Subjects requiring systemic therapy with corticosteroids (> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before the first dose of study drug; 4. Patients who have received antitumor vaccine or received live vaccine within 4 weeks before the first dose of study drug; 5. BMI = 10% within 2 months before screening; 6. Patients whose imaging shows that the tumor has invaded important organs and blood vessels, or the investigators judge that the tumor is likely to invade important blood vessels and cause fatal hemorrhage during the follow-up period; 7. A bleeding disorder or previous history of a bleeding disorder; 8. Subjects who are considered not suitable for surgery or unable to tolerate surgery by the investigator's evaluation; 9. Major surgery or severe trauma within 4 weeks before the first dose of study drug; 10. Patients with CTCAE grade >= 3 peripheral neuropathy; 11. Patients with active autoimmune diseases, a history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism after thyroid hormone replacement therapy could be included. Patients with vitiligo, cured childhood asthma/allergies without any intervention in adulthood, and type I diabetes with stable doses of insulin are excluded. 12. A history of immunodeficiency, including testing positive for HIV, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation or allogeneic bone marrow transplantation; 13. Subjects with uncontrolled cardiovascular clinical symptoms or diseases; 14. Severe infection (CTCAE grade > 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; 15. The subjects having a history of interstitial lung disease and non-infectious pneumonia; 16. The subjects with active hepatitis B and hepatitis C; 17. Any other malignant tumor diagnosed before the first use of the study drug, except basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid cancer that could be treated locally and cured; 18. Women who are pregnant or lactating subjects of childbearing potential who are unwilling or unable to take effective contraceptive 19. Other circumstances deemed inappropriate by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Pathologic Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation completion rate;R0 removal rate;Primary pathological response rate (MPR);Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactDai Liang
Beijing Cancer Hospital
Outcome results
None listed