Esophageal cancer
Conditions
Interventions
Therapy group:Adebrelimab + albumin-paclitaxel + nedaplatin, 3 cycles before surgery
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old, no limit to male or female; 2. Resectable locally advanced esophageal squamous cell carcinoma confirmed by histology or cytology (clinical stage: stage IIa-IIIb); 3. There are measurable and/or non-measurable lesions that meet the definition of Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4. Have not received any anti-tumor systemic treatment for esophageal cancer in the past; 5. ECOG PS: 0-1 points; 6. Expected survival =12 weeks; 7. The functions of vital organs meet the following requirements: a) Routine blood examination (no blood transfusion within 14 days, no correction with hematopoietic stimulating factor drugs): Hemoglobin (Hb) =90 g/L; absolute neutrophil count (ANC) =1.5×109/L; platelets (PLT) =100×109/L; white blood cell count (WBC) =3.0×109/L; b) Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5×ULN; serum total bilirubin (TBIL) =1.5×ULN (Gilbert syndrome subjects, = 3×ULN); serum creatinine (Cr) =1.5 ×ULN or creatinine clearance =50ml/min; c) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =1.5×ULN; d) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) =50%; 8. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who are non-surgically sterilized must have a negative serum or urine HCG test within 72 hours before study enrollment; For males, they should be surgically sterilized, or agree to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug; 9. The patient voluntarily joined this study, signed the informed consent form (ICF), had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with locked lymph node metastasis; 2. Pregnant or lactating women, or those with childbearing potential but refuse to take contraceptive measures; 3. Have a history of other malignant tumors in the past 5 years, except for cervical carcinoma in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled; 4. Are receiving any of the following treatments: 1) Have received any investigational drugs within 4 weeks before the first use of investigational drugs; 2) Subjects who need to be given corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before using the study drug for the first time, except for treatment of local inflammation of the esophagus, prevention of allergies, and use of corticosteroids for nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids are allowed at doses >10 mg/d of prednisone or equivalent corticosteroids; 3) Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of study drugs; 5. Suffering from bleeding disorders or a history of bleeding disorders; 6. Have undergone major surgery or serious trauma within 4 weeks before taking the study drug for the first time; 7. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 8. Have a history of interstitial lung disease and non-infectious pneumonia; 9. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection 1 year ago but without formal treatment; 10. Suffering from active autoimmune diseases or a history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Reduced thyroid function after thyroid hormone replacement therapy can be eligible; 11. Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 12. Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to: 1) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 13. Severe active infection requiring intravenous antibiotic treatment occurs within 4 weeks before using the study drug; 14. Those who are allergic to experimental drugs; 15. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits; 16. Those who the researcher believes are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate;Explore the mechanism by which the immune microenvironment affects the efficacy of immunotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Major pathological response rate;Objective response rate;Disease-free survival;Overall survival;Patient-reported outcomes;Safety; | — |
Countries
China
Contacts
Public ContactJianqun Ma
Harbin Medical University Cancer Hospital
Outcome results
None listed