Local Advanced Esophageal Cancer
Conditions
Interventions
Experimental group:Nimotuzumab in Combined with Chemoradiotherapy
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent form; 2. Age: 18-75 years; 3. Pathologically proven squamous cell carcinoma of esophagus; 4. Inoperable, stage II-III and initial esophageal cancer; 5. ECOG performance status 0-2; 6. No pregnant or lactating, the fertility of male or female willing to take contraceptive measures during the study; 7. No serious hematopoietic function, heart, lung, liver, kidney dysfunction and immune deficiency; 8. Adequate organic function must be according with the following: WBC more than 4 000/uL, Haemoglobin more than 9g/dL(without blood transfusion), Absolute neutrophil count (ANC) more than 2100/uL; 9. Platelets more than 100000/uL, total bilirubin more than 1.5*upper limit of normal, AST (SGOT)/ALT (SGPT) less than 2.5*upper limit of normal. Creatinine more than 1.5*upper limit of normal; 9. Weight loss less than 10% within 6 months before radiotherapy; 10. Life expectancy longer than 3 months; 11. No history of prior tumors, or that has been treated with a curative intent with a 5-year disease-free survival; 12. Good compliance.
Exclusion criteria
Exclusion criteria: 1. Radiotherapy, chemotherapy, surgical resection of esophageal cancer or targeted therapy prior to treatment; 2. Deep ulcers or perforation or hematemesis; 3. Other malignancies but exception of curative skin cancer(non-melanoma), cervical carcinoma in situ or malignant disease curatively more than 5; 4. Distant metastasis; 5. Participation in another clinical trial at the same time; 6. Participation in another clinical trial within 30 days prior to inclusion in the trial; 7. History of known hypersensitivity to nimotuzumab or similar agents; 8. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; 9. Drug abuse, long-term alcoholics, and AIDS patients; 10. Uncontrollable seizures, or loss of insight because of mental illness; 11. The researchers do not think participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactJiancheng LI
Outcome results
None listed