esophageal squamous cell carcinoma
Conditions
Interventions
Case series:Chemotherapy combined with Tislelizumab
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years old; 2. Patients diagnosed with esophageal squamous cell carcinoma after tissue or cytological examination; 3. Patients with resectable tumor confirmed by two senior thoracic surgeons doctors base on that the eighth edition of AJCC is in stage II-IVA (T2-4aNxM0; at T2N0M0, the length of the tumor >=2cm under endoscopic examination); the tumor is located below the neck and >=5cm from the cricopharyngeal muscle; 4. Patients with a complete imaging examination and no distant metastasis is seen; (1) Neck ultrasound and chest/abdomen enhanced CT; (2) When clinical or cervical ultrasound suspects cervical lymph node metastasis, ultrasound-guided lymph node biopsy or PET/CT; (3) When CT examination suspects liver metastasis, perform plain abdominal scan and enhanced MRI or PET/CT to confirm the diagnosis; (4) If there are symptoms of general pain, add bone scan if necessarye) Clear staging by ultrasound gastroscopy (5) Patients who have not received any treatment related to tumor diseases (including radiotherapy and chemotherapy, targeted therapy, immunotherapy or Chinese medicine treatment); 5. Patients with ECOG score 0-1. The quality of life score is evaluated according to the activity status score table [1] developed by the Eastern Cooperative Oncology Group (ECOG); 6. Patients with sufficient organ and bone marrow function, meeting the following definitions: 7. Blood routine (no blood transfusion, no use of granulocyte colony stimulating factor (G-CSF), no correction with other drugs within 14 days before treatment); 8. Neutrophil count (NE)>1500/uL; 9. Hemoglobin count (HGB)>8.0 g/dL; 10. Platelet count (PLT)>100 000/uL; 11. Blood biochemistry (liver function); 12. Serum creatinine (Cr) <=2.5 ULN; 13. Total bilirubin (TBIL) <=2.5 ULN; 14. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <=2.5 ULN; 15. Patients who agree and sign an informed consent form, and follow the planned visits, research and treatment, laboratory inspections and other test procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have received the following medical interventions within four weeks before treatment; 2. Patients who have received surgery, radiotherapy, chemotherapy, immune or molecular targeted therapy for tumors; 3. Patients who participate in other clinical research drug treatments; 4. Patients with history of vaccination with live attenuated vaccine; 5. Patients who previously received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-1 ligand, PD-L1) monoclonal antibodies, cytotoxic lymphocyte associated antigen 4 (cytotoxic T lymphocyte -associated antigen-4, CTLA-4) antibody or other immune or molecular targeted therapy; 6. Patients who plan to conduct radiotherapy for esophageal squamous cell carcinoma during the study period; 7. Patients with distant metastasis of the tumor after the imaging diagnosis; Neck ultrasound and chest/abdomen enhanced CT suggest other organ metastases; Other organ metastases confirmed by PET/CT or MRI; 8. Patients with esophageal squamous cell carcinoma with interstitial pneumonia or pulmonary fibrosis; 9. Patients who have used immunosuppressive drugs and glucocorticoids in the past 7 days before starting treatment; 10. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function Hyperthyroidism, hypothyroidism), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Patients who have active infection occurred 4 weeks before treatment (such as intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5 degree C during screening/before first administration; 12. Patients with any other malignant tumor diagnosed before treatment; 13. Patients allergic to the study drug or any of its excipients, or have a severe allergic reaction to other monoclonal antibodies; 14. Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures; 15. Patients with concomitant diseases (such as poorly controlled hypertension, poorly controlled diabetes, poorly controlled diabetes, Neurological or mental illness, etc.) or any other condition according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response rate, MPR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological Complete Response rate, pCR rate;R0 removal rate;Objective response rate, ORR;Disease-free survival, DFS;Event-free survival, EFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactXiaolong Yan
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed