Actively Recruiting
Nituzumab (Taixinsheng ®） A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Combined Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinomatreatment of Locally Advanced Nasopharyngeal Carcinoma
Led by Sichuan Cancer Hospital and Research Institute · Updated on 2025-04-09
170
Participants Needed
1
Research Sites
288 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nasopharyngeal carcinoma (NPC) is a head and neck tumor. Studies have shown that more than 70% of patients are diagnosed with locally advanced nasopharyngeal carcinoma at the time of initial diagnosis. The 3-year survival rate of locally advanced nasopharyngeal carcinoma after chemotherapy is over 90%, but 30% of patients still have recurrence and distant metastasis. Therefore, while improving the level of radiation therapy technology, we should study multidisciplinary comprehensive treatment methods and put forward the biological concept of "cure". Induction chemotherapy can effectively create better radiotherapy conditions for locally advanced nasopharyngeal carcinoma, especially for patients with large lesions, improve the treatment response rate, and may reduce the local recurrence and distant metastasis rate. After the end of neoadjuvant chemotherapy, compared with patients who only reached SD, patients who reached CR had a significant survival benefit; Other patients had a reduced rate of distant metastasis, which aroused our interest, although there was no obvious survival benefit. The national multicenter phase II clinical study showed that nitumab combined with radiotherapy significantly improved the 3-year survival rate of patients with locally advanced nasopharyngeal carcinoma compared with radiotherapy alone. According to the previous related research results, nitumab combined with induction chemotherapy or concurrent chemoradiotherapy has a certain effect on nasopharyngeal carcinoma without obvious adverse reactions. However, prospective studies on the short-term efficacy and safety of local advanced nasopharyngeal carcinoma combined with induction chemotherapy and concurrent chemoradiotherapy are still lacking (Taisheng ®）。
CONDITIONS
Official Title
Nituzumab (Taixinsheng ®） A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study on the Efficacy and Safety of Combined Induction Chemotherapy for Locally Advanced Nasopharyngeal Carcinomatreatment of Locally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 70 years, any gender
- Histopathological diagnosis of nasopharyngeal squamous cell carcinoma
- Staging per 2018 AJCC: T2-4N2M0 with specific lymph node risk factors or T1-4N3M0
- Positive EGFR expression by immunohistochemistry
- Measurable primary tumor
- Karnofsky score greater than 70
- Expected survival of at least 6 months
- Women of childbearing potential must use effective contraception during the study
- Hemoglobin level at least 90 g/L, white blood cells at least 4 x 10^9/L, platelets at least 90 x 10^9/L
- Liver function tests ALT and/or AST less than 1.5 times upper normal limit; total bilirubin less than 1.5 times upper normal limit
- Renal function: serum creatinine less than 1.5 times upper normal limit; creatinine clearance rate at least 60 ml/min
You will not qualify if you...
- Evidence of distant metastasis
- Prior surgical treatment of primary tumor or lymph nodes except biopsy
- Prior radiotherapy to primary tumor or lymph nodes
- Previous epidermal growth factor targeted therapy
- Prior chemotherapy or immunotherapy for primary lesion
- History of other malignancies except non-melanoma skin cancer or cervical carcinoma in situ
- Participation in other drug trials within the past month
- Peripheral neuropathy greater than grade 1
- Pregnant or breastfeeding women or women refusing contraception during study
- Severe allergy history or special constitution
- Severe lung or heart disease history
- Known HIV infection or active viral hepatitis
- Received live vaccine within 30 days before starting study drug
- Unable or unwilling to sign informed consent
- Drug or alcohol addiction
- Personality or mental illness with limited or no legal capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
M
MEI FENG, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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