Esophageal squamous cell carcinoma
Conditions
Interventions
Test group:Camrelizumab + nab-paclitaxel + platinum
Sponsors
The Affiliated Hospital of Inner Mongolia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in the trial: 1. 18 years old=10mm, the short diameter of lymph nodes with CT scan is greater than or equal to 15mm;); 6. Those who were initially diagnosed with esophageal squamous cell carcinoma before enrollment, who have not undergone radiotherapy, chemotherapy, surgery and targeted therapy; 7. Intended for neoadjuvant therapy; 8. The main organs are functioning normally, that is, the following criteria are met: (1) Routine blood examination must meet (no blood transfusion, no hematopoietic factor and no drug correction within 14 days): a. ANC >= 1.5×109/L; b. PLT >= 100×109/L; c. HB >= 90 g/L; (2) The biochemical examination shall meet the following standards: a. TBIL =50mL/min (CockcroftGault formula); (3) Coagulation function must meet: INR<=1.5×ULN and APTT<=1.5×ULN; 9.Female subjects of childbearing age must have a negative serum pregnancy test within 3 days before starting the study drug, and be willing to use a medically approved high-efficiency contraceptive during the study and within 3 months after the last dose of the study drug measures (such as: intrauterine device, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, he should agree the surgical sterilization, or agree to use effective sterilization during the study period and within 3 months after the last study dose method of contraception. 10. The subjects voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following were not eligible for this study: 1. There is central nervous system transfer; 2. Those with contraindications to surgery; 3. Suffering from any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, Hypothyroidism (may be included after hormone replacement therapy); patients with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood may be included; patients requiring medical intervention with bronchodilators are not included; 4. Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV RNA higher than the analysis detection limit of the method) or co-infection with hepatitis B and C; 5. Administered immunosuppressive drugs within 14 days prior to first use of study drug, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (i.e. no more than 10 mg/day prednisone or its equivalent) ); 6. Administer a live attenuated vaccine within 4 weeks before the first dose or during the study period; 7. Suffering from other malignant tumors in the past 3 years; 8. There is evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment; 9. Uncontrolled hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg despite optimal medical therapy); 10. Patients with grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval >=450ms for men and >=470ms for women). According to NYHA criteria, patients with grade III-IV cardiac insufficiency, or cardiac ultrasound examination showed that left ventricular ejection fraction (LVEF) 38.5°C during screening/before the first dose; 12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 13. Pregnant or breastfeeding women; fertile patients who are unwilling or unable to take effective contraceptive measures; 14. Known allergic reactions, hypersensitivity reactions or intolerance to camrelizumab, nab-paclitaxel platinum or their excipients; 15. Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or 5 half-lives of the research drug; 16. The subject has a known history of psychotropic substance abuse, alcohol or drug abuse; 17. The investigator believes that there are any conditions that may harm the subject or prevent the subject from meeting or performing the research requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;ORR;DFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactShirong Kang
The Affiliated Hospital of Inner Mongolia Medical University
Outcome results
None listed