Esophageal carcinoma
Conditions
Interventions
Experimental group:PD-1 antibody combined with chemotherapy sequential concurrent chemoradiotherapy as neoadjuvant therapy, radical surgery within 4-8 weeks after the completion of neoadjuvant therapy
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients eligible for this study must meet the following criteria: 1. Sign a written informed consent before any trial-related procedures; 2. Male or female, aged 18 years or older, and 75 years or younger; 3. Diagnosed with esophageal squamous cell carcinoma at the thoracic segment, confirmed by primary lesion biopsy and pathological tissue examination; Patients who are judged to be operable and require neoadjuvant treatment based on imaging and esophagogastroduodenoscopy cT3-4aN0M0, cT1b-4aN+M0, stages II-IVa, according to the 8th edition of the AJCC At least one measurable lesion by imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 The patient has not received any antitumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. 7. ECOG score of 0-1 points; 8. In addition, the participant must meet the following laboratory criteria: 1) Within the past 14 days, without the use of granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) should be >= 1.5x10^9/L. 2) Within the past 14 days, without blood transfusion, the platelet count should be >= 100x10^9/L. 3) Hemoglobin > 9g/dL within the past 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin = 60 ml/min 7) Coagulation function is good, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 times the upper limit of normal (ULN); 8) Thyroid function is normal, defined as Thyroid-Stimulating Hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled; 9) Cardiac enzymes are within the normal range (even if the researcher judges that a simple laboratory abnormality without clinical significance is allowed to be enrolled) 10) For female subjects of childbearing age, a urine or serum pregnancy test should be performed and the result should be negative within 3 days before the first administration of the study drug (Day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing women are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 11)If there is a risk of pregnancy, all subjects (male or female) must use contraception with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy) at the end of treatment.
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria cannot be enrolled in this study: 1. Patients diagnosed with other malignant tumors within 5 years prior to the first dose and not cured (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Currently participating in interventional clinical study treatment, or having received other investigational drugs or used investigational device treatment within 4 weeks prior to the first dose; 3. Prior treatment with the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Received systemic systemic therapy with anti-tumor proprietary Chinese medicine or immunomodulatory effect within 2 weeks before the first dose; 5. Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 6. Systemic glucocorticoid therapy (excluding nasal, inhaled, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiologic doses of glucocorticoids ( =2 chronic heart failure; Myocardial infarction within 6 months prior to ran
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Recurrence-Free Survival (RFS);Major Pathological Response (MPR);Grade=3 Adverse Events (CTCAE v5.0); | — |
Countries
China
Contacts
Public ContactZhang,JIngjing
Department of Thoracic Oncology Radiotherapy, Zhongshan City People's Hospital
Outcome results
None listed