Esophageal cancer
Conditions
Interventions
Experimental group:Two cycles (21 days per cycle) of carilizumab combined with platinum-containing chemotherapy (albumin paclitaxel + nedaplatin) were received as neoadjuvant therapy
Sponsors
Shandong First Medical University Affiliated Tumour Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18-75 years; 3. Patients diagnosed with esophageal squamous cell carcinoma (cervical or thoracic esophagus cancer requires >5cm away from the cricopharyngeal muscle) by histopathological examination of the primary tumor biopsy, and patients with clinical stage cT1b-cT2 N+ or cT3-cT4aNany; 4. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 5. The patient has not received any anti-tumor therapy before, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 6. ECOG score 0-1 points; 7. Sufficient organ function, patients should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >=100x10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin>9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin =60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, patients with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that the simple laboratory abnormality does not have clinical significance, it is also allowed to be included in the group); 8. For patients of childbearing age, a urine or serum pregnancy test should be taken within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1) with a negative result. If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Patients of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 9. If there is a risk of conception, all patients (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of the study drug (or 180 days after the last chemotherapy drug dose).
Exclusion criteria
Exclusion criteria: 1. Lactating subjects; 2. Those who are known to be allergic to the study drug or its excipients; 3. The subject has any active autoimmune disease or has a history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, subjects with vitiligo or complete remission of asthma in childhood without any intervention can be included, subjects requiring bronchodilator for medical intervention are not included); 4. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; 5. Subjects with congenital or acquired immunodeficiency (such as HIV infection) or active hepatitis (Hepatitis B refers to HBsAg positive and HBV DNA detection value exceeds the upper limit of normal value, hepatitis C refers to HCV antibody positive and HCV virus titer detection value exceeds the upper limit of normal value); 6. The subject has previously or concurrently suffered from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 7. Live vaccines within 4 weeks before the study medication or possibly during the study period; 8. Any other factors deemed inappropriate by the investigator to enter the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathological response rate;recurrence-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactDong Yinjun
Shandong First Medical University Affiliated Tumour Hospital
Outcome results
None listed