Esophageal squamous cell carcinoma
Conditions
Interventions
cocurrent chemoradiotherapy:cocurrent chemoradiotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years of age; 2. Histopathological confirmed esophageal squamous carcinoma; 3. Clinical stage T1-2N1-3M0 or T3NanyM0 (AJCC, 8th edition, 2017) with the upper boundary of the tumor at least 5 cm from the esophageal inlet; 4. Not having received antitumor-related treatment; 5. Evaluation based on the activity scale developed by the Eastern Cooperative Oncology Group (ECOG), which includes patients with an ECOG score of 0-1; 6. Adequate organ function. (1) Blood count (no blood transfusion, no granulocyte colony-stimulating factor (G-CSF), no other drug correction within 14 days prior to treatment); Neutrophil count (NE) >1500/µL; hemoglobin count (HGB) >8.0 g/dL; platelet count (PLT) >100 000/µL. (2) Blood biochemistry (liver and kidney function) Serum creatinine (Cr) <= 1.5 x the upper limits of normal (ULN). Total bilirubin (TBIL) <= 1.5 x ULN. Glutamic aminotransferase (AST) or glutamic alanine aminotransferase (ALT) level <= 2 x ULN 7. Sign the informed consent form for participation in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients who have received the following medical interventions within 4 weeks prior to treatment (1) Drug therapy involved in other clinical studies. (2) History of live attenuated vaccination. 2. Prior anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibody, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or other immune or molecularly targeted therapies; 3. Patients who are entirely unable to eat; 4. with pre-existing esophageal perforation or at high risk of esophageal perforation; 5. cannot tolerate surgery in the judgment of the investigator; 6. Patients with combined interstitial pneumonia, non-infectious pneumonia or pulmonary fibrosis; 7. prior use of the immunosuppressive drug glucocorticoids within 7 days prior to initiation of treatment; 8. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. active infection prior to treatment (e.g. requiring intravenous antibiotics, antifungal or antiviral drugs) or unexplained fever >38.5°C during screening/before the first dose; 10. Metal implants or foreign bodies in the body (including but not limited to pacemakers, and neurostimulators) 11. a diagnosis of any other malignancy prior to treatment; 12. known hypersensitivity to the investigational drug or any of its excipients, or a history of severe allergic reaction to other monoclonal antibodies; 13. not using reliable contraception during pregnancy or lactation and in women of childbearing age; 14. Presence of concomitant disease that, in the investigator's judgment, seriously jeopardizes the subject's safety, may confound the study's results, or interfere with the subject's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Countries
China
Contacts
Public ContactBingwen Zou
Westchina Hospital, Sichuan University
Outcome results
None listed