esophageal squamous cell carcinoma
Conditions
Interventions
Single-Arm Trial: According to the tumor CPS score, patients with CPS =10 will receive neoadjuvant immunotherapy (Serplulimab 300 mg administered intravenously
each cycle is 21 days, for a total of 2 cycles).
Sponsors
Shanghai Geriatric Medical Center
Eligibility
Sex/Gender
All
Age
75 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with a pathological diagnosis of squamous cell carcinoma confirmed by gastroscopic biopsy, with tissue specimens collected before treatment (PD-L1 protein expression detected using the 22C3 antibody and CPS scoring); 2. The primary tumor is located in the thoracic esophagus. The location of the primary esophageal cancer is determined by the position of the upper edge of the tumor in the esophagus (upper thoracic esophagus: from the thoracic inlet to the lower edge of the azygos vein arch, 20 cm to 75 years, ECOG performance status 0–1 (see Appendix 1), and estimated survival >=12 months; 5. Subjects have no major organ dysfunction, and routine blood tests, pulmonary, hepatic, renal, and cardiac functions are basically normal. Laboratory test indicators must meet the following requirements: Blood: White blood cell count >4.0×10?/L, absolute neutrophil count (ANC) >=2.0×10?/L, platelet count >100×10?/L, hemoglobin >90g/L; Pulmonary function: FEV1 >=1.2L, FEV1% >=50%, and DLCO >=50% (Note: FEV1(L): measured forced expiratory volume (L). FEV1%: measured/expected forced expiratory volume %. DLCO%: measured/expected single-breath carbon monoxide diffusing capacity %); Liver function: Serum bilirubin =60 ml/min; 6. Able to understand the details of this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients determined by imaging examinations such as contrast-enhanced chest and abdominal CT, cervical lymph node ultrasound, whole-body PET-CT (optional), or EBUS (optional) to have a clinical stage of (AJCC/UICC 8th Edition) T4b unresectable disease (as determined by two senior thoracic surgeons), multiple enlarged lymph nodes (estimated lymph node metastases >=3), multiple lymph node stations involved (estimated metastatic lymph node stations >=2), or distant metastasis (M1); 2. Patients who have received or are currently receiving other chemotherapy, immunotherapy, radiotherapy, or targeted therapy; 3. Pathology by gastroscopy indicates non-squamous cell carcinoma; 4. History of other malignancies (except for patients with cured cervical carcinoma in situ or locally cured basal cell carcinoma of the skin); Other exclusion criteria: 5. History of autoimmune disease; 6. Recent or current use of corticosteroids exceeding 10 mg/day; 7. Previous immunotherapy; 8. History of severe hypersensitivity to antibody drugs; 9. History or presence of chronic or recurrent autoimmune diseases; 10. Interstitial lung disease, pulmonary fibrosis, diverticulitis, or systemic ulcerative gastrointestinal inflammation; 11. Documented history of congestive heart failure; poorly controlled angina; transmural myocardial infarction confirmed by ECG; poorly controlled hypertension; clinically significant valvular heart disease; or high-risk, uncontrolled arrhythmia; 12. Severe, uncontrolled systemic intermittent disease, such as active infection or poorly controlled diabetes; coagulation dysfunction, bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy; 13. Positive serum pregnancy test or breastfeeding women, and men or women of childbearing potential unwilling to use adequate contraception during the study drug treatment period; 14. Known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), or known HIV seropositivity; including HBV or HCV surface antigen positivity (RNA); 15. Known allergy to any study drug; 16. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 17. Presence of peripheral nervous system disorders or significant psychiatric disorders and history of central nervous system disorders; 18. Concurrent use of anti-tumor drugs outside of the study protocol; 19. Simultaneous participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year Progression Free Survival;2 year Overall Survival; | — |
Countries
China
Contacts
Public ContactFang Yong
Shanghai Geriatric Medical Center
Outcome results
None listed