Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Biological: Nimotuzumab
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-70 years Histological confirmed Cervical squamous cell carcinoma FIGO Stage: IB2-IIIB 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. At least one lesions can be measured No previous therapy ECOG performance status 0-2 Life expectancy of more than 6 months 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 Without lung or heart disease Without active infection Signed informed consent and submit to the organization of research Exclusion Criteria: Severe systemic or uncontrolled disease, unfit for chemotherapy Neuropathy caused by any reason Psychiatric disease Other malignant tumor Bilateral renal pelvis and ureter hydrocephalus who can't be alleviated by ureteral stent or percutaneous nephrostomy, Abnormal serum creatinine level Infection and severe systemic disease Received other anti EGFR monoclonal antibody treatment Participation in other interventional clinical trials Allergic constitution or history of drug allergy Pregnant or breast-feeding or refused to take contraceptive method Poor compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab plus chemoradiotherapy<br> | Biological: Nimotuzumab<br>* 200mg/w,weekly, 6 weeks<br>Drug: Carboplatin<br>* AUC 6, d1，1 cycle/21d, 2 cycles<br>Drug: Paclitaxel<br>* 175 mg/m2, d1 1 cycle/21d, 2 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resection rate |  | the day right after surgery | 
| Pathological response rate |  | the day right after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |