Esophageal neoplams
Conditions
Interventions
Test group:Nimotuzumab, Albumin paclitaxel, Cisplatin, radiotherapy
Sponsors
Cangzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, gender is not limited; 2. ECOG PS score 0-1; 3. Stage IIb-IIIc esophageal squamous cell carcinoma diagnosed by histopathology or cytology; 4. Histopathological immunohistochemical detection indicated that EGFR expression was positive, weakly positive, and negative; 5. Patients who are not suitable for surgery (defined as patients whose physical condition does not allow or refuses surgery for various reasons); 6. According to the RECIST version 1.1 evaluation criteria, at least one measurable lesion, CT scan >=10mm; 7. Suitable for radiotherapy and chemotherapy for the purpose of radical cure; 8. Hematological indicators are basically normal: white blood cell count >=4x10^9/L; absolute neutrophil count >=1.5x10^9/L; platelets >=100x10^9/L; hemoglobin >=90 g/L ; 9. Basically normal renal function: serum creatinine=60mL/min; 10. Liver function is basically normal: serum total bilirubin<=1.5xULN (if liver metastasis, serum total bilirubin should be<=3.0xULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<=2.5x ULN (<=5.0xULN, if there is liver metastasis); 11. Female patients must have a negative urine pregnancy test before the start of the study (not applicable to bilateral oophorectomy and/or hysterectomy patients or postmenopausal patients); 12. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI therapy, anti-angiogenic drugs, immunosuppressive drugs within half a year; 2. Participated in other interventional clinical trials within 30 days before screening; 3. Patients with distant metastasis; 4. Patients with other primary malignant tumors other than esophageal cancer (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for more than 5 years); 5. There are concurrent diseases that are poorly controlled (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); 6. Known infection with HIV or active viral hepatitis and other infectious diseases; 7. Those who are allergic to the drugs or their components used in this program; 8. According to the criteria of Common Adverse Event Terms (NCI CTCAE V5.0), >= grade 2 peripheral nerve disease or hearing loss; 9. Lactating women, or subjects of childbearing age who are unwilling or unable to take effective contraceptive measures (both male and female subjects) until at least 6 months after the last trial treatment; 10. The researcher believes that it is not suitable to participate in this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;2-year and 3-year Overall survival rate;2-year and 3-year progression-free survival; | — |
Countries
China
Contacts
Public ContactWang Ming
Cangzhou Central Hospital
Outcome results
None listed