esophagus cancer
Conditions
Interventions
Group 1 :Nituzumab combined with chemotherapy
Sponsors
Cancer Hospital Affiliated to Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, male or female; 2. Esophageal squamous cell carcinoma confirmed by histology or cytology with locally advanced unresectable, local recurrence or distant metastasis; 3. Have not received anti-tumor therapy for esophageal cancer, including chemotherapy and local therapy; 4. According to RECIST 1.1, there should be at least one measurable lesion, and the measurable lesion should not receive local treatment such as radiotherapy; 5. EGFR immunohistochemistry or FISH detection of tumor tissue samples were positive; 6. Tissue samples should be provided for biomarker analysis, and newly obtained tissues are preferred. Patients who cannot provide newly obtained tissues can provide 8-10 paraffin sections with thickness of 5 um for archiving; 7. ECOG: 0-1; 8. Expected survival >= 12 weeks; 9. The major organs function normally, that is, meet the following criteria: (1) Blood routine examination: 1) HBG >= 90 g/L; 2) ANC >= 1.5 x 10^9/L; 3) PLT >= 80 x 10^9/L; (2) Biochemical examination: 1) ALB >= 30 g/L; 2) ALT and AST = 60 ml/min; 10. Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the low limit of normal value (50%); 11. Women of reproductive age should agree to use contraceptives (such as Iuds, 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 a non-lactating patient; men who should agree to use contraception during the study period and for 6 months after the study period ends; 12. The subjects voluntarily joined the study, signed the informed consent, complied well, and cooperated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or has autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; the patient had vitiligo; those with complete remission of asthma in childhood can be included without any intervention in adulthood; patients with asthma requiring medical intervention with bronchodilators are not included); 2. Patients who were taking immunosuppressant or systemic hormone therapy for immunosuppressive purposes (dose > 10 mg/day prednisone or other therapeutic hormone) and continued to use it within 2 weeks prior to enrollment; 3. Previous treatment with EGFR monoclonal antibody or EGFR tyrosine kinase inhibitors; 4. Previously received other PD-1 antibody therapy or other PD-1/PD-L1 immunotherapy; 5. Patients with brain metastases accompanied by symptoms or symptoms controlled for less than 3 months; 6. Patients with any severe and/or uncontrolled disease, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QT interval >= 480 ms), and grade I cardiac insufficiency; (2) Active or uncontrolled severe infection; (3) Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >= 10^4 copy number/ml or 2000 IU/ml), or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of assay); 7. Patients whose imaging shows that the tumor has invaded important vascular peripherals or whose tumor is judged by the investigator to be highly likely to invade important vascular peripherals and cause fatal massive hemorrhage during the follow-up study; 8. Patients with other malignancies within 5 years (other than cured basal cell carcinoma of the skin and cervical carcinoma in situ); 9. Patients who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; 10. Patients who have participated in clinical trials of other drugs within four weeks; 11. Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study; 12. Patients deemed unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate of tumor;Overall tumor survival;Tumor disease control rate;Tumor progression-free survival;Duration of tumor remission;Time from tumor to remission; | — |
Countries
China
Contacts
Public ContactMa Jianqun
Cancer Hospital Affiliated to Harbin Medical University
Outcome results
None listed