Esophageal cancer patients diagnosed by histopathology or cytology, with pathological staging of cT1b-cT2N+or cT3-CT4aNany
Conditions
Interventions
Trial group:Adelimumab: 1200 mg administered by intravenous infusion on Day 1 of each cycle, every 3 weeks (Q3W)
Nab-paclitaxel: 200 mg/m^2, IV, D1, Q3W
Carboplatin: AUC = 5, IV, D1, Q3W, for a total of 2 cycles.
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years, no gender restrictions; 2.Patients with resectable esophageal squamous cell carcinoma diagnosed by histopathology or cytology; 3.Patients with pathological staging of cT1b-cT2N+or cT3-CT4aNany. 4.ECOG score 0-1 points; 5.Expected survival period = 12 weeks; 1..6.Participants voluntarily joined this study, signed informed consent forms, had good compliance, and cooperated with follow-up; 7. The functions of major organs meet the following requirements (no use of any blood products, growth factors, white blood cell boosters, platelet stimulants, or anemia-correcting drugs is allowed within 14 days before the first use of the investigational drug); (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (2) Platelets >= 100 × 10^9/L; (3) Hemoglobin >= 10 g/dL; (4) Serum albumin >= 2.8 g/dL; (5) Total bilirubin 60 mL/min; (7) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 × ULN; 8.The ejection fraction in the echocardiogram before the start of treatment is greater than 50%; 9.No history of surgical resection;
Exclusion criteria
Exclusion criteria: 1.Distant metastasis or infiltration of adjacent tissues or organs, all primary unresectable stages; 2.Recurrent patients; 3.BMI=10% within 2 months prior to screening (taking into account the impact of large amounts of ascites on weight); 4.History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication; 5.Previous history of allergies to any component of monoclonal antibody Adabelimab, albumin paclitaxel, carboplatin, or any component thereof; 6. Have received any of the following treatments: (1) Previous treatment with anti-PD-1 or anti-PD-L1 antibodies; (2) Received any investigational drugs within 4 weeks prior to the first administration of the study drug; (3) Simultaneously enrolled in another clinical study, unless it is an observational (non-interventional) study or interventional study follow-up; (4) Participants requiring systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first administration of the study drug; (5) Received any anti-tumor vaccines or live vaccines within 4 weeks prior to the first administration of the study drug; (6) Underwent major surgery or trauma within 4 weeks prior to the first administration of the study drug; 7.Patients with active autoimmune diseases or a history of autoimmune diseases, excluding vitiligo or childhood asthma/allergies that have already recovered, who do not require any intervention in adulthood; Thyroid hypofunction received by autoimmunity was treated with thyroid replacement hormone at a stable dose, and type I diabetes was treated with insulin at a stable dose. 8.History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; 9.Participants have uncontrolled cardiovascular clinical symptoms or diseases; 10.Serious infections (CTCAE>grade 2) occurred within the first 4 weeks prior to the first use of the investigational drug, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral and intravenous antibiotic treatment, except for prophylactic use of antibiotics. 11.History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) and history of non infectious pneumonia; 12.Patients with active pulmonary tuberculosis infection detected through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis interference more than one year ago but without formal treatment; 13.Peripheral neuropathy>NCI Grad II; 14.Pregnant or lactating women;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological response;R0 resection rate;Disease Control Rate (DCR);Event-Free Survival (EFS);Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactLi Lin
Qilu Hospital of Shandong University
Outcome results
None listed