Esophageal cancer
Conditions
Interventions
Experimental group:Platinum-Based Doublets (2 Cycles) Combination with Tislelizumab to One Year
Control group:Tislelizumab Only to One Year
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and older, no gender limits. 2. Histopathologically confirmed esophageal squamous cell carcinoma; Stage II (cT2N1M0 only) to IVA (8th UICC/AJCC TNM classification) thoracic esophageal cancer. 3. Right-sided transthoracic esophagectomy with at least two-field lymph node dissection via conventional or minimal invasive thoracotomy with gastric conduit reconstruction and a cervical (McKeown) or intrathoracic (Ivor Lewis) anastomosis. 4. All surgical margins were microscopically negative. 5. Histologically node-positive (y)pN1 disease. 6. Good Eastern Cooperative Oncology Group (ECOG) performance status scores (0 or 1). 7. Sufficient tissue for PD-L1 expression assessment. 8. Voluntarily signing an informed consent participation agreement.
Exclusion criteria
Exclusion criteria: 1. Severe morbidity (Clavien-Dindo classification greater than grade IIIa). 2. Receiving previous anti-tumor immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibodies or drugs that target T cell co-stimulation or checkpoint pathways specifically) before enrollment. 3. Receiving any form of adjuvant therapy (e.g., radiotherapy, chemotherapy, targeted, immunotherapy, or anti-tumor vaccine therapy). 4. Previous history of other malignancies, unless complete remission has been achieved at least five years before study entry, and no additional treatment is required or expected to be required during the study period (exceptions, including, but not limited to, non-melanoma skin cancer; carcinoma in situ of the bladder or colon or cervix; breast carcinoma in situ, etc.) 5. Complicated with active autoimmune diseases, or history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes). Except: vitiligo, cured childhood asthma/allergic adults without any intervention, autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, and type I diabetes with a stable dose of insulin. 6. Receiving corticosteroid (> 10mg daily prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 14 days before administering the study drug; allowing absence of active autoimmune disease, inhaled or topical steroids of > 10mg daily prednisone equivalent, and adrenal substitute steroids. 7. A history of immunodeficiency, including HIV positive, acquired or congenital immunodeficiency diseases, organ transplantation, or bone marrow transplantation. 8. Active hepatitis B (quantity of HBV DNA >= 100 IU/mL), or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analytical method) infection. 9. Complicated with chronic nephritis, or urine routine test indicates urine protein >= ++, or 24-hour urine protein >= 1.0 g. 10 Pregnant women, breastfeeding mothers, and women of childbearing age with a positive or missing pregnancy test were not eligible. 11. Received a live attenuated vaccine within 30 days of initial treatment. 12. Allergic to any PD-1 antibodies or chemotherapy agents. 13. Any severe or uncontrolled medical disease or active infection, significant abnormal laboratory test values, or family or social factors, etc. that, based on the clinical judgment of the investigators, may increase the risk of enrollment, drug administration, or impair patients' capability to receive treatment under the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;1,2,3-year Overall Survival Rates;Recurrence Pattern (Local Regional and Metastatic);Treatment Related Adverse Events;Patient-Reported Outcomes, PROs; | — |
Countries
China
Contacts
Public ContactLi Yin
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed