Cervical Cancer
Conditions
Brief summary
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phaseⅡtrial is designed to assess the resection rate and pathological complete response of nimotuzumab plus carboplatin and paclitaxel in patients with cervical cancer.
Interventions
BIOLOGICALNimotuzumab
200mg/w,weekly, 6 weeks
DRUGCarboplatin
AUC 6, d1，1 cycle/21d, 2 cycles
DRUGPaclitaxel
175 mg/m2, d1 1 cycle/21d, 2 cycles.
Sponsors
Biotech Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age:18-70 years 2. Histological confirmed Cervical squamous cell carcinoma 3. FIGO Stage: IB2-IIIB 4. Tumor lesions and stages are confirmed by the internal medicine, obstetrics and gynecology inspection, including a pelvic exam and abdominal and pelvic CT,.if necessary, laparoscopy, cystoscopy and pelvic MRI examination will be taken. 5. At least one lesions can be measured 6. No previous therapy 7. ECOG performance status 0-2 8. Life expectancy of more than 6 months 9. Normal hematology:Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L, normal renal function: serum creatinine\<1.5mg/dl or creatinine clearance rate\>60ml/min；normal liver function:TBIL≤1.5 ULN, AST and ALT≤1.5 ULN 10. Without lung or heart disease 11. Without active infection 12. Signed informed consent and submit to the organization of research
Exclusion criteria
1. Severe systemic or uncontrolled disease, unfit for chemotherapy 2. Neuropathy caused by any reason 3. Psychiatric disease 4. Other malignant tumor 5. Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level 6. Infection and severe systemic disease 7. Received other anti EGFR monoclonal antibody treatment 8. Participation in other interventional clinical trials 9. Allergic constitution or history of drug allergy 10. Pregnant or breast-feeding or refused to take contraceptive method 11. Poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| resection rate | the day right after surgery |
| Pathological response rate | the day right after surgery |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate（ORR） | The first seven weeks after the end of treatment |
| Progression free survival progression-free survival (PFS) | Follow-up is for three consecutive years after surgery. Once every three months in the first year, and then once every six months in the second and third year. |
Countries
China
Outcome results
None listed