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Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Carboplatin
Paclitaxel
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai first people's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab plus chemoradiotherapy

Arm Description

Outcomes

Primary Outcome Measures

resection rate
Pathological response rate

Secondary Outcome Measures

objective response rate(ORR)
Progression free survival progression-free survival (PFS)

Full Information

First Posted
January 8, 2014
Last Updated
August 17, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02039791
Brief Title
Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Official Title
Phase II Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab plus chemoradiotherapy
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nimotuzumab
Intervention Description
200mg/w,weekly, 6 weeks
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 6, d1,1 cycle/21d, 2 cycles
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m2, d1 1 cycle/21d, 2 cycles.
Primary Outcome Measure Information:
Title
resection rate
Time Frame
the day right after surgery
Title
Pathological response rate
Time Frame
the day right after surgery
Secondary Outcome Measure Information:
Title
objective response rate(ORR)
Time Frame
The first seven weeks after the end of treatment
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yaping Zhu
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai first people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

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Study of Nimotuzumab in Combination With Neoadjuvant Chemotherapy for Cervical Cancer

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