Trial Title:
Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
NCT ID:
NCT05717790
Condition:
Nasopharyngeal Carcinoma by AJCC V8 Stage
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Gemcitabine
Nimotuzumab
Conditions: Keywords:
Nimotuzumab
Nasopharyngeal Carcinoma
Induction Chemotherapy
Chemoradiation
Adjuvant Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nimotuzumab
Description:
Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg
will be given weekly for 6 cycles, started on day 1 of induction chemotherapy.
Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant
therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.
Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .
Arm group label:
Control
Arm group label:
Experimental: Nimotuzumab arm
Other name:
h-R3
Other name:
BIOMAb EGFR
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2
cycles
Arm group label:
Control
Arm group label:
Experimental: Nimotuzumab arm
Other name:
GEM
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2
cycles.
Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3
cycles.
Arm group label:
Control
Arm group label:
Experimental: Nimotuzumab arm
Other name:
DDP
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiotherapy
Description:
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
Arm group label:
Control
Arm group label:
Experimental: Nimotuzumab arm
Other name:
IMRT
Summary:
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located
in the extra cellular domain of the human epidermal growth factor receptor (EGFR).
Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck
(SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center,
randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and
safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and
adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 to 70.
2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria).
3. Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the
8th edition clinical staging system of the American Joint Committee on Cancer
[AJCC]/Union for International Cancer Control [UICC].
4. ECOG performance score: 0 to 1.
5. Primary lesions can measurable.
6. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and
platelet count ≥100×10e9/L.
7. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of
normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula).
8. Patients must sign informed consent and be willing and able to comply with the
requirements of visits, treatment, laboratory tests and other research requirements
stipulated in the research schedule.
Exclusion Criteria:
1. Primary lesions or lymph node have been operated (except of operation for biopsy).
2. Previous Received other anti EGFR monoclonal antibody treatment;Previous
chemotherapy or immunization therapy.
3. Other malignant tumor.
4. Participation in other interventional clinical trials within 1 month.
5. History of Serious lung or heart disease.
6. Pregnant or breast-feeding women and women who refused to take contraceptive method.
7. Drug abuse or alcohol addiction.
8. History of serious allergic or allergy.
9. Refused or can't signed informed consent form.
10. Other patients who are considered ineligible for the study by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
People's Hospital of Baise
Address:
City:
Baise
Zip:
533000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiliang Meng
Email:
337468010@qq.com
Facility:
Name:
Affiliated Hospital of Youjiang Medical University for Nationalities
Address:
City:
Baise
Zip:
533099
Country:
China
Status:
Recruiting
Contact:
Last name:
Tingzhuang Yi
Email:
ytz20070101@163.com
Facility:
Name:
Guilin Medical University, China
Address:
City:
Guilin
Zip:
541000
Country:
China
Status:
Recruiting
Contact:
Last name:
Meilian Liu
Email:
liu.meilian@163.com
Facility:
Name:
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Address:
City:
Guilin
Zip:
541000
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongmei Wu
Email:
wudongmei06@163.com
Facility:
Name:
the Fourth Affiliated Hospital of Guangxi Medical University
Address:
City:
Liuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xishan Chen, Master
Email:
344135841@qq.com
Facility:
Name:
Second Affiliated Hospital of Guangzhou Medical University
Address:
City:
Nanjing
Zip:
530000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Li
Email:
13978896800@163.com
Facility:
Name:
The First People's Hospital of Qinzhou
Address:
City:
Qinzhou
Zip:
535000
Country:
China
Status:
Recruiting
Contact:
Last name:
Baoqing Yang
Email:
460200267@qq.com
Facility:
Name:
Wuzhou Red Cross Hospital
Address:
City:
Wuzhou
Zip:
543000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianquan Gao
Email:
gjq2369712@sina.com
Facility:
Name:
Liuzhou People's Hospital
Address:
City:
Liuzhou
Zip:
545000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Wang
Email:
wjszr2018@126.com
Start date:
December 1, 2022
Completion date:
November 30, 2027
Lead sponsor:
Agency:
Fourth Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
People's Hospital of Baise
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Agency class:
Other
Collaborator:
Agency:
Guilin Medical University, China
Agency class:
Other
Collaborator:
Agency:
LiuZhou People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Qinzhou
Agency class:
Other
Collaborator:
Agency:
Wuzhou Red Cross Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Youjiang Medical University for Nationalities
Agency class:
Other
Source:
Fourth Affiliated Hospital of Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717790
