Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Biotech Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Carboplatin; Biological: Nimotuzumab; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT02039791

BT-IST-CC-072

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Nimotuzumab plus chemoradiotherapy

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Biological: Nimotuzumab