esophageal squamous carcinoma
Conditions
Interventions
Experimental group:2 cycles of neoadjuvant therapy, with each treatment cycle lasting 3 weeks (Q3W):
1. Adebrelimab 1200 mg, intravenous infusion, on day 1, Q3W
2. Albumin-bound paclitaxel 125 mg/m^2, intravenous infusion, on days 1 and 8, Q3W.
Sponsors
Fujian Medical University First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form and voluntarily join this study; 2. Age = 70 years, both men and women are eligible; 3. Histologically or cytologically confirmed esophageal squamous cell carcinoma; 4. Clinical stage of cT1b-cT2N M0 or cT3-cT4a any N M0; 5. At least one measurable lesion (according to RECIST 1.1 standards, the measurable lesion must have a longest diameter =10 mm by spiral CT or malignant lymph node short diameter =15 mm); 6. Candidates expected to achieve R0 resection; 7. ECOG PS 0-1 (see Appendix 1); 8. No prior anti-tumor treatment for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; 9. Plan to undergo surgery after completing neoadjuvant therapy; 10. No contraindications to surgery; 11. Normal major organ function, including: (1) Complete blood count (no blood products, growth factors, leukocyte-stimulating drugs, platelet-stimulating drugs, or anemia-correcting drugs allowed within 14 days prior to first use of the study drug): 1) White blood cell count >= 3.0 × 10^9/L 2) Neutrophil count >= 1.0 × 10^9/L 3) Platelet count >= 80 × 10^9/L 4) Hemoglobin >= 90 g/L (2) Blood biochemistry tests: 1) Total bilirubin = 50 mL/min (Cockcroft-Gault formula, see Appendix 2) (3) Coagulation function: 1) International Normalized Ratio (INR) <= 1.5 × ULN 2) Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN 12. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours before starting the study drug, and must use effective contraception during the trial and for at least 3 months after the last dose (e.g., intrauterine device, contraceptive pills, or condoms); male subjects with partners of childbearing age must use effective contraception during the trial and for 3 months after the last dose. 13. Subjects must have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Tumor significantly invades organs adjacent to the esophageal lesion (such as major arteries or the trachea); 2. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage; 3. Poor nutritional status, BMI 10 mg/day prednisone or equivalent) within 2 weeks before first use of the study drug; inhaled or local steroid use and adrenal corticosteroid replacement at doses >10 mg/day prednisone or equivalent are allowed in the absence of active autoimmune disease; (3) Receipt of live attenuated vaccine within 4 weeks before first use of the study drug; (4) Undergoing major surgery or experiencing severe trauma within 4 weeks before first use of the study drug; 6. Having any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (consideration may be given after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have completely resolved and require no intervention in adulthood may be considered, but those requiring medical intervention with bronchodilators are excluded; 7. History of immunodeficiency, including HIV positive test, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation; 8. Presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure NYHA class II or above, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that are uncontrolled despite clinical intervention; 9. Severe infection (CTCAE > grade 2) within 4 weeks prior to first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection-related complications, etc.; baseline chest imaging suggesting active pulmonary inflammation, symptoms and signs of infection within 14 days prior to the first use of the study drug, or requiring oral or intravenous antibiotic treatment, except for prophylactic antibiotic use; 10. Active tuberculosis infection detected by medical history or CT examination, or a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year ago that was not properly treated; 11. Hereditary bleeding tendency or coagulation dysfunction. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or baseline fecal occult blood positive or above; 12. Diagnosis of another malignant tumor within 5 years prior to first use of the study drug, unless it is a malignant tumor with low risk of metastasis or d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate (MPR);R0 resection rate;Objective response rate (ORR);Disease Control Rate (DCR);Recurrence-free survival time (RFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactFancai Lai
Fujian Medical University First Affiliated Hospital
Outcome results
None listed