This trial is active, not recruiting.

Condition cervical cancer
Treatments nimotuzumab, carboplatin, paclitaxel
Phase phase 2
Target EGFR
Sponsor Biotech Pharmaceutical Co., Ltd.
Start date January 2013
End date June 2016
Trial size 20 participants
Trial identifier NCT02039791, BT-IST-CC-072


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
200mg/w,weekly, 6 weeks
AUC 6, d1,1 cycle/21d, 2 cycles
175 mg/m2, d1 1 cycle/21d, 2 cycles.

Primary Outcomes

resection rate
time frame: the day right after surgery
Pathological response rate
time frame: the day right after surgery

Secondary Outcomes

objective response rate(ORR)
time frame: The first seven weeks after the end of treatment
Progression free survival progression-free survival (PFS)
time frame: 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.

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Principal investigator yaping Zhu
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Biotech Pharmaceutical Co., Ltd..