esophageal squamous carcinoma
Conditions
Interventions
control Group:Nimotuzumab, Tegafur Gimer and radiotherapy
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 60-80 years old, male or female; (2) ECOG PS score 0-1; (3) Patients with histologically confirmed (stage II/III) locally advanced esophageal cancer; (4) Positive EGFR immunohistochemistry or FISH test results in tumor tissue samples; (5) Patients unsuitable for surgery (defined as patients whose physical condition does not allow or who refuse surgery for various reasons); (6) At least one measurable lesion according to RECIST Version 1.1 evaluation criteria; (7) Receiving concurrent chemoradiotherapy and targeted therapy, and tolerable; (8) Expected survival time >= 3 months; (9) Hematological parameters are basically normal: white blood cell count >= 4 x 10^9/L; absolute neutrophil count >= 1.5 x 10^9/L; platelets >= 100 x 10^9/L; hemoglobin >= 90 g/L; (10) Basically normal renal function: serum creatinine = 60 mL/min (11) Liver function is basically normal: serum total bilirubin <= 1.5 x ULN (if there is liver metastasis, serum total bilirubin should be <= 3.0 x ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN (<= 5.0 x ULN, if there is liver metastasis). (12) Patients sign written informed consent.
Exclusion criteria
Exclusion criteria: (1) Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs and anti-angiogenic drugs within half a year; (2) Patients with severe underlying diseases who cannot tolerate chemoradiotherapy; (3) Participation in other interventional clinical trials within 30 days prior to screening; (4) History of other malignancies (except cured cervical carcinoma in situ or cutaneous basal cell carcinoma and other malignancies that have been cured for more than 5 years); (5) Presence of concurrent diseases with poor control (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); (6) Known infection with HIV or active viral hepatitis; (7) Presence of multilevel esophageal malignancy; (8) Patients who are allergic to the drugs or their ingredients used in this protocol; (9) Grade >= 2 peripheral nerve disease or hearing loss according to the criteria of the Common Adverse Event Term (NCI CTCAE V5.0); (10) The investigators think it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);2-year progression-free survival (PFS) rate;Median overall survival (mOS); | — |
Countries
China
Contacts
Public ContactLiu Xiancheng
Affiliated Hospital of Nantong University
Outcome results
None listed