Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Last updated: August 17, 2015
Sponsor: Biotech Pharmaceutical Co., Ltd.
Overall Status: Trial Status Unknown

Phase

2

Condition

Pelvic Cancer

Vaginal Cancer

Dysfunctional Uterine Bleeding

Treatment

N/A

Clinical Study ID

NCT02039791
BT-IST-CC-072
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andgynecology inspection, including a pelvic exam and abdominal and pelvic CT,.ifnecessary, 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 neutrophilcount≥1.5×109/L,platelet count≥100×109/L, normal renal function: serumcreatinine<1.5mg/dl or creatinine clearance rate>60ml/min;normal liverfunction: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

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 ureteralstent 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

Study Design

Total Participants: 20
Study Start date:
January 01, 2013
Estimated Completion Date:
August 31, 2016

Connect with a study center

  • Shanghai first people's hospital

    Shanghai, Shanghai 200080
    China

    Site Not Available

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