Esophageal Squamous Carcinoma
Conditions
Interventions
A :Nimotuzumab
Sponsors
Affiliated hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18-75 years of age, including 18 and 75 years of age; No gender limitation (2) KPS score is greater than 60 points; (3) Patients with early postoperative recurrence of esophageal squamous cell carcinoma diagnosed pathologically or cytologically (according to AJCC Version 8); (4) The recurrent site is the anastomosis and its adjacent area, and the residual stomach could not be avoided by local radiotherapy. (5) At least one measurable lesion with a CT scan of = 10 mm according to RECIST version 1.1; (6) Immunohistochemical detection of pathological tissues will be performed to confirm the expression intensity of EGFR, which is weakly positive (+), moderately positive (++), and strongly positive (+++). (7) Hematological indicators will be basically normal: white blood cell count = 4× 109/L; Absolute neutrophil count = 1.5× 109/L; Platelets = 100× 109/L; Hemoglobin = 90 g/L; (8) Renal function is essentially normal: serum creatinine =1.2mg/dL or creatinine clearance =60mL/min (9) Liver functions will be almost normal: total serum bilirubin =1.5×ULN (total serum bilirubin should = 3.0× ULN if liver metastasis is present); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)=2.5×ULN(=5.0×ULN, if liver metastases will be present). (10) Female patients must have a negative urine pregnancy test prior to study initiation (not applicable in patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients) (11) Sign the written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who have received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI treatment, anti-angiogenic drugs and immunosuppressive agents within six months; (2) Other interventional clinical trials within 30 days before screening; (3) Patients with distant metastasis; (4) Patients with primary malignant tumors other than esophageal cancer (except cured cervical carcinoma in situ, breast carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for more than 5 years); (5) Concurrent diseases with poor control (such as heart failure, diabetes, hypertension, thyroid disease and mental disease); (6) Known to be infected with HIV virus or active sexually transmitted diseases, toxic hepatitis and other infectious diseases; (7) Allergic to the drugs or their components used in this scheme; (8) Grade =2 peripheral nerve disease or hearing loss according to the criteria for the term common adverse event (NCI CTCAE V5.0); (9) Pregnant (confirmed by blood or urine HCG testing) or lactating women, or subjects of childbearing potential who are unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last test treatment; (10) The researcher did not consider it appropriate to participate in the study; (11) Subjects who did not wish to participate in the study or will be unable to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (progression-free survival);DCR (Disease Control Rate);OS (overall survival); | — |
Countries
China
Contacts
Public ContactZhou Jialiang
Outcome results
None listed