Esophageal Carcioma
Conditions
Interventions
Nimotuzumab combined with sintilizumab treatment group:Nimotuzumab combined with sintilizumab
Sponsors
The Sixth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old, both male and female; (2) Esophageal squamous cell carcinoma confirmed by histology or cytology, locally advanced unresectable, local recurrence, or distant metastasis; (3) Patients who have progressed or become intolerant of first-line chemotherapy (including platinum, taxon or fluorouracil-based) (the progress of maintenance treatment after first-line chemotherapy can also be included). Concurrent chemoradiation and chemotherapy for postoperative recurrence or metastasis are considered first-line treatment; for radical concurrent chemoradiation, neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if the disease progresses during treatment or within 6 months after stopping treatment, Count it as a failure of first-line treatment; (4) According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), there is at least one measurable lesion, and the measurable lesion should not have received local treatment such as radiotherapy (lesions located in the area of ??previous radiotherapy, if it is confirmed to have progressed, and meet RECIST1. 1 standard, can also be selected as target lesions.); (5) EGFR immunohistochemistry or FISH test positive in tumor tissue samples; (6) Tissue samples must be provided for biomarker analysis, and newly obtained tissues are preferred. Patients who cannot provide newly obtained tissues can provide 8-10 5um-thick paraffin sections for archive preservation; (7) ECOG: 01; (8) Expected survival period >= 12 weeks; (9) The main organs function normally, that is, they meet the following standards: (1) Routine blood examination: a.HBG >= 90g/L; b.ANC >= 1.5 * 10^9/L; c.PLT >= 80 * 10^9/L; (2) Biochemical inspection: a.ALB >= 30g/L; b.ALT and AST = 60ml/min; (10) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%). (11) Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum or urine pregnancy test within 7 days before study entry Patients who are negative and must be non-lactating patients; men who agree to use contraceptive measures during the study period and within 6 months after the end of the study period; (12) Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: (1) The patient has any active autoimmune disease or autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, Nephritis, hyperthyroidism; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included); (2) The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes (dose > 10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment; (3) Have received EGFR monoclonal antibody or EGFR tyrosine kinase inhibitor treatment in the past; (4) Have received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1 in the past; (5) Patients with brain metastases who are accompanied by symptoms or whose symptoms have been controlled for less than 3 months; (6) Patients with any severe and/uncontrolled diseases, including: Patients with poor blood pressure control (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >= 480ms), and grade I cardiac insufficiency; Active or uncontrolled serious infection; Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >= 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the detection limit of the analysis method); (7) Patients whose imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study; (8) Pregnant or lactating women; (9) Patients suffering from other malignant tumors within 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ); (10) People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; (11) Patients who have participated in other drug clinical trials within four weeks; (12) According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; (13) The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the size of the tumor;overall survival;objective remission rate; | — |
Countries
China
Contacts
Public ContactLu Zejun
The Sixth Medical Center of PLA General Hospital
Outcome results
None listed