Esophageal squamous cell carcinoma
Conditions
Interventions
Group 1:Adebelimab plus nab-paclitaxel plus nidaplatin
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
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 esophageal squamous cell carcinoma confirmed by pathological histology or cytology; 3. Patients with clinical stage cT1b-cT2N+ or cT3-cT4aNian. 4. ECOG score of 0-1; 5. Expected survival>=12 weeks; 6. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up; 7. 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); a 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 60mL/min; g Activated partial thromboplastin time (APTT) and international normalized ratio (INR) 50% on echocardiography before treatment starts; 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. Relapsed patients; 3. BMI=10% within 2 months prior to screening (while considering the impact of massive ascites on body weight); 4. History of gastrointestinal perforation and/or fistula within 6 months prior to the first dose; 5. Previous history of allergy to any component of monoclonal antibody adebelimab, albumin-paclitaxel, nedaplatin or any component thereof; 6. Patients with contraindications to any component of monoclonal antibody adebelimab, nab-paclitaxel, and nidaplatin; 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 require systemic treatment with corticosteroids (> 10mg prednisone equivalent dose per day) or other immunosuppressants 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 prior to the first dose of study drug; f Those who have undergone major surgery or trauma within 4 weeks before the first use of study drug;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;R0 resection rate;Objective response rate;Disease control rate;Event-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactWenfeng Yang
Cancer Hospital Affiliated to Shandong First Medical University
Outcome results
None listed