Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Adebrelimab combined with chemotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed an informed consent form, and cooperated with follow-up; 2. Esophageal squamous cell carcinoma confirmed by histology/cytology; 3. Evaluated by CT/MRI/EUS, it is thoracic esophageal cancer with clinical staging cT1N1-2M0, cT2-3/N0-2/M0 (according to AJCC 8th edition); 4. Have not received anti-tumor treatment in the past, including radiotherapy, chemotherapy, surgery, etc; 5. Age range from 18 to 75 years old, regardless of gender; 6. Plan to undergo surgical treatment after the completion of neoadjuvant therapy; 7. There are no surgical contraindications in preoperative organ function tests; 8.ECOG PS: 0-1 points; 9. Important organ functions meet the following requirements (no blood components or cell growth factors are allowed to be used 2 weeks before starting the study and treatment): The blood routine examination must meet the following criteria: Absolute neutrophil count (ANC) = 1.5 × 109/L; Hemoglobin (HB) = 9g/dL; Platelet count (PLT) = 100 × 109/L; Serum albumin (ALB) = 2.8g/dL. Biochemical examination must comply with: Total bilirubin (TBIL) = 1.5 × ULN; ALT and AST = 2.5 × UILN (if liver dysfunction is caused by liver metastasis, = 5 × ULN); Serum creatinine sCr = 1.5 × ULN, endogenous creatinine clearance rate = 50ml/min (Cockcroft Gault formula); Thyroid function is normal. Coagulation function must comply with: International normalized ratio (INR) = 1.5 x ULN; Activated partial thromboplastin time (APTT) = 1.5 x ULN. 10. Expected survival time = 3 months; 11. The researchers determined that the patient can receive treatment with adebrelimab combined with chemotherapy; 12. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and demonstrate a negative result. They are willing to use effective contraception methods from the trial period to 3 months after the last administration of adebrelimab; For male participants whose partners are women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last administration of adebrelimab; 13. The subjects have good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) The tumor clearly invades adjacent organs (large arteries or trachea) of the esophageal lesion; (2) Individuals with supraclavicular lymph node metastasis; (3) There are uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage; (4) Poor nutritional status, BMI10mg/day prednisone or equivalent dose); In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and adrenal cortex hormone substitutes with a dose>10mg/day prednisone or equivalent dose; c) Received attenuated live vaccine within 4 weeks prior to the first use of the study drug; d) Having undergone major surgery or severe trauma within 4 weeks prior to the first use of the investigational drug; (7) Suffering from any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Patients with psoriasis or childhood asthma/allergies that have completely relieved and do not require any intervention in adulthood may be considered for inclusion, but patients who require medical intervention with bronchodilators may not be included; (8) Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation or allogeneic bone marrow transplantation; (9) There are clinical symptoms or diseases of the heart that cannot be well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina, (3) myocardial infarction occurred within one year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention; (10) Serious infections (CTCAE>grade 2) occurred within 4 weeks prior to the first use of the investigational drug, such as severe pneumonia, bacteremia, and infection complications that require hospitalization; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, excluding prophylactic use of antibiotics; (11) Individuals who have been diagnosed with active pulmonary tuberculosis infection through medical history or CT examination, or have had a history of active pulmonary tuberculosis infection within one year prior to enrollment, or have had a history of active pulmonary tuberculosis infection more than one year prior but have not received formal treatment; (12) There is active hepatitis B (HBV DN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate (MPR);Objective response rate (ORR);Overall survival (OS);Event Free Survival (EFS); | — |
Countries
China
Contacts
Public ContactYong Yuan
West China Hospital of Sichuan University
Outcome results
None listed