esophageal cancer
Conditions
Interventions
Intervention group:Carrelizumab + carboplatin + paclitaxel
Sponsors
Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this study and signed informed consent; 2. Patients with histologically confirmed esophageal squamous cell carcinoma (cervical or thoracic esophageal carcinoma > 5cm from the circumpharyngeal muscle) with clinical staging of cT1b-cT2N + or cT3-cT4aNany; 3. Aged 18-70 years; 4. ECOG PS score: 0~1; 5. Major organ functions within 7 days prior to treatment shall meet the following criteria: (1) Standard of blood routine examination (without transfusion within 14 days): hemoglobin (HB) >=90g/L; Neutrophil absolute value (ANC) >=1.5x10^9/L; Platelet (PLT) >=80x10^9/L; (2) Biochemical examination should meet the following criteria: total bilirubin (TBIL) =60ml/min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)>= the lower limit of normal value (50%); 6. Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for six months after the study; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should consent to patients who must use contraception during the study period and for 6 months after the study period ends; 7. No active uncontrolled infection except for chronic viral hepatitis receiving antiviral treatment; 8. Treatment within 30 days prior to the clinical trial without receiving other experimental drugs or other anticancer treatments.
Exclusion criteria
Exclusion criteria: 1. Patients who have received systematic tumor therapy before; 2. Pregnant or lactating patients; Fertile patients who are unwilling or unable to take effective contraceptive measures; 3. Known allergy to the investigational drug or its excipients; 4. Patient has any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Patients who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Patients with asthma requiring medical intervention with bronchodilators are not included); 5. Clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA2 + heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 6. Patients with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive, HBV DNA test value exceeds the upper limit of normal value; Hepatitis C reference: HCV antibody positive, and HCV virus titer test value above the upper limit of normal); 7. Patient has had or co-has other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ); 8. Live vaccine was administered less than 4 weeks before or possibly during the study; 9. Any other factors deemed unsuitable for inclusion in the test by the investigator; 10. Patients at potential risk for bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological response;disease free survival;R0 resection rate;overall survival; | — |
Countries
China
Contacts
Public ContactSheng Wei
Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed