Actively Recruiting
Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Led by Fourth Affiliated Hospital of Guangxi Medical University · Updated on 2023-02-08
288
Participants Needed
9
Research Sites
260 weeks
Total Duration
On this page
Sponsors
F
Fourth Affiliated Hospital of Guangxi Medical University
Lead Sponsor
P
People's Hospital of Baise
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosed with non-keratinizing carcinoma type nasopharyngeal carcinoma
- Locoregionally advanced nasopharyngeal carcinoma (stage III-IV, except T3N0) based on AJCC 8th edition
- ECOG performance score of 0 to 1
- Primary tumors must be measurable
- Adequate blood counts: neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L
- Liver function tests ALT/AST ≤ 2.5 times upper normal limit and creatinine clearance ≥ 50 ml/min
- Able and willing to sign informed consent and follow study visits, treatments, and tests
You will not qualify if you...
- Prior surgery on primary tumor or lymph nodes (except biopsy)
- Previous treatment with anti-EGFR monoclonal antibodies, chemotherapy, or immunotherapy
- Presence of other cancers
- Participation in other interventional trials within last month
- History of serious lung or heart disease
- Pregnant or breastfeeding women, or refusal to use contraception
- Drug abuse or alcohol addiction
- History of serious allergies
- Unable or unwilling to provide informed consent
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 9 locations
1
People's Hospital of Baise
Baise City, Guangxi, China, 533000
Actively Recruiting
2
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise City, Guangxi, China, 533099
Actively Recruiting
3
Guilin Medical University, China
Guilin, Guangxi, China, 541000
Actively Recruiting
4
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, China, 541000
Actively Recruiting
5
the Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, China
Actively Recruiting
6
Second Affiliated Hospital of Guangzhou Medical University
Nanjing, Guangxi, China, 530000
Actively Recruiting
7
The First People's Hospital of Qinzhou
Qinzhou, Guangxi, China, 535000
Actively Recruiting
8
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543000
Actively Recruiting
9
Liuzhou People's Hospital
Liuzhou, Other (Non U.s.), China, 545000
Actively Recruiting
Research Team
Y
Ying Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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