esophageal squamous cell carcinoma
Conditions
Interventions
Group 1:Concurrent chemoradiotherapy
Sponsors
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male and female subjects are eligible; 2. Patients with esophageal squamous cell carcinoma confirmed by histopathology or cytology; 3. Patients with clinical stage cT3–cT4aN0 or cT2–cT4aN+ esophageal cancer deemed resectable upon surgical evaluation; 4. ECOG performance status 0 or 1; 5. Expected survival of at least 12 weeks; 6. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to complete follow-up visits. 7. Functions of vital organs shall meet the following criteria (No blood products, cell growth factors, leukopoietic agents, thrombopoietic agents, or anemia-correcting agents are permitted within 14 days prior to the first administration of study drug); (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (2) Platelet count >= 100 × 10^9/L; (3) Hemoglobin >= 10 g/dL; (4) Serum albumin >= 2.8 g/dL; (5) Total bilirubin 60 mL/min; (7) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) 50% on echocardiography prior to treatment initiation; 9. No prior surgical resection history.
Exclusion criteria
Exclusion criteria: 1. All unresectable primary disease stages with distant metastasis or invasion of adjacent tissues or organs; 2. Patients with recurrent esophageal squamous cell carcinoma; 3. BMI 10 mg prednisone daily) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug; (5) Subjects who have received anti-tumor vaccines, or received live vaccines within 4 weeks prior to the first dose of study drug; (6) Subjects who have undergone major surgery or sustained traumatic injury within 4 weeks prior to the first dose of study drug; 7. Presence of active autoimmune disease, or history of autoimmune disease, with the following exceptions: patients with vitiligo, or childhood asthma/allergies that have fully resolved and require no intervention in adulthood; autoimmune hypothyroidism treated with stable-dose thyroid replacement hormone; type 1 diabetes mellitus controlled with stable-dose insulin; 8. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, or prior history of solid organ transplantation and allogeneic hematopoietic stem cell transplantation; 9. Subjects with inadequately controlled cardiovascular clinical signs or diseases; 10. Severe infection (CTCAE Grade > 2) occurring within 4 weeks prior to the first administration of study drug, including severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active pulmonary inflammation indicated by baseline chest imaging; presence of infectious signs and symptoms within 2 weeks prior to the first study drug dose, or requirement for oral or intravenous antibiotic therapy, excluding prophylactic antibiotic use; 11. Prior interstitial lung disease (except untreated radiation pneumonitis) or non-infectious pneumonitis; 12. Active tuberculosis detected by medical history or CT, prior active tuberculosis within 1 year before enrollment, or remote active tuberculosis (more than 1 year ago) without standardized treatment; 13. Peripheral neuropathy = NCI Grade 2; 14. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Event-Free Survival (EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);2 year Event Free Survival (EFS) rate;1 year Event Free Survival (EFS) rate;Safety and Quality of Life (QoL);Disease Control Rate (DCR);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactHuang Wei
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Outcome results
None listed