Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Single-Arm:Low-dose radiotherapy combined with chemoimmunotherapy as neoadjuvant treatment
Sponsors
Daping Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, both male and female; 2. Initially diagnosed with surgically resectable cT1-4aN+M0 or cT3-4aN0M0 thoracic esophageal squamous cell carcinoma confirmed by histology or cytology; 3. No prior local or systemic antitumor treatment for esophageal cancer; 4. ECOG score of 0-1; 5. Function of vital organs meets the following criteria: a) Absolute neutrophil count >= 1.5 × 10?/L; b) Platelets >= 80 × 10?/L; c) Hemoglobin >= 80 × 10?/L; d) Total bilirubin <= 1.5 × upper limit of normal (ULN); e) Serum creatinine within normal range; f) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN; g) No history of severe comorbidities or other major diseases that have not been cured; 6. Deemed resectable and able to tolerate surgery by a thoracic surgeon; 7. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use a medically approved contraceptive method during the study treatment period and for at least 6 months after the last chemotherapy; 8. Subjects voluntarily join this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Tumors with tracheal/bronchial/great vessel invasion or deeply ulcerated esophageal cancer; 2. Patients with gastrointestinal perforation and/or fistula, major bleeding within 6 months prior to enrollment, or those with poor pulmonary function or chronic interstitial lung disease. 3. Known allergy or hypersensitivity to biologics produced by Chinese Hamster Ovary (CHO) cells or any component of PD-1 monoclonal antibody preparations. 4. History of allergy to albumin-bound paclitaxel, carboplatin, or other platinum-based drugs. 5. Prior or ongoing treatments including: a) Concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or follow-up phases of interventional trials. b) Subjects requiring systemic treatment with corticosteroids (equivalent to prednisone =10 mg/day) or immunosuppressive agents within 2 weeks before the first dose of the study drug, excluding the use of corticosteroids for local esophageal inflammation, allergy prevention, or management of nausea and vomiting. Topical or inhaled steroids are permitted in the absence of active autoimmune diseases. If immunosuppressive drugs are unexpectedly required during the trial, their use will be allowed but dose reduction is strongly recommended as soon as possible. c) Administration of antitumor vaccines or live vaccines within 4 weeks prior to the first dose of the study drug. 6. Active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these conditions); exceptions include vitiligo or resolved childhood asthma/allergies that require no intervention in adulthood. Autoimmune-mediated hypothyroidism managed with stable thyroid hormone replacement therapy, and type I diabetes controlled with stable insulin regimens are allowed. 7. History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation. 8. Poorly controlled cardiovascular diseases or clinical symptoms, including but not limited to: a) Heart failure of NYHA class II or higher. b) Unstable angina. c) Myocardial infarction within the past year. d) Clinically significant supraventricular or ventricular arrhythmias that are uncontrolled despite intervention. 9. Active hepatitis B (chronic or acute; defined as HBsAg-positive with HBV DNA >1000 copies/mL) or hepatitis C. 10. Patients with active tuberculosis (diagnosed based on clinical history, physical examination, imaging findings, and local standard TB tests). 11. Severe infections (CTCAE grade >2) within 4 weeks prior to the first dose of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or complicated infections; active pulmonary inflammation indicated by baseline chest imaging, or signs/symptoms of infection within 2 weeks before the first dose requiring oral or intravenous antibiotics (excluding prophylactic antibiotic use). 12. Major surgery within 28 days before treatment (excluding diagnostic surgery) or anticipated major surgery during the study period. 13. Diagnosis of any other malignancy within 5 years prior to the first dose of the study drug, except for malignancies with low risk and mortality (5-year survival rate >90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma i
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response, MPR;Disease-Free Survival, DFS;Event-Free Survival, EFS;Overall Survival, OS;Objective Response Rate, ORR;Surgical Completion Rate;R0 Resection Rate;Safety; | — |
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response, pCR; | — |
Countries
China
Contacts
Public ContactMengxia Li
Daping Hospital, Army Medical University
Outcome results
None listed