Esophageal squamous cell carcinoma
Conditions
Interventions
Group 1:Preoperative neoadjuvant adebelimab plus nab-paclitaxel combined with cisplatin, postoperative adebelimab maintenance therapy.
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Patients with resectable squamous cell carcinoma with resectable stage cT1b-cT2N+ or cT3-cT4aNany confirmed by pathological histology or cytology; 3. ECOG score 0-1 points; 4. Expected survival>=12 weeks; 5. Subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with follow-up; 6. The function of vital organs meets the following requirements (no blood components, cell growth factors, whitening drugs, platelet-raising drugs, and anemia-correcting drugs are allowed within 14 days before the first use of the study drug); Absolute neutrophil count (ANC) >=1.5*10^9/L; b Platelets>=100*10^9/L; c Hemoglobin >=10g/dL; d Serum albumin>=2.8g/dL; e Total bilirubin 60 mL/min; g Activated partial thromboplastin time (APTT) and international normalized ratio (INR) 50% on echocardiography before the start of treatment; 8. No history of surgical resection of esophageal squamous cell carcinoma;
Exclusion criteria
Exclusion criteria: 1. Distant metastasis or infiltration of adjacent tissues or organs, all primary unresectable stages; 2. Relapsed patients; 3. BMI =10% (while considering the impact of a large amount of ascites on body weight); 4. History of gastrointestinal perforation and/or fistula within 6 months before the first dose; 5. History of previous allergy to any component of monoclonal antibody adebelimab, albumin paclitaxel, cisplatin or any component thereof; 6. Patients with contraindications to monoclonal antibodies, adebelimab monoclonal antibody, albumin, paclitaxel, cisplatin; 7. Have received any of the following treatments: a Prior treatment with anti-PD-1 or anti-PD-L1 antibodies; b Receipt of any investigational drug within 4 weeks prior to the first use of the drug; c Enrollment in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; d Subjects who need to be given corticosteroids (10 mg prednisone equivalent dose per >day) or other immunosuppressants for systemic therapy within 2 weeks prior to the first use of study drug; e Those who have been vaccinated with anti-tumor vaccines or have received live vaccines within 4 weeks before the first dose of study drug; f Those who have undergone major surgery or trauma within 4 weeks before the first use of the study drug; 8. Patients with active autoimmune diseases, history of autoimmune diseases, except for vitiligo or childhood asthma/allergies that have been cured, and do not require any intervention in adulthood; Autoimmune patients treated with a stable dose of thyroid replacement hormone for hypothyroidism, using a stable dose of insulin for type I diabetes. 9. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary pathological remission rate;R0 resection rate;Objective response rate;Disease control rate;No event survival period;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactLin Zhang
Shandong Provincial Hospital
Outcome results
None listed