Treatment for locally advanced nasopharyngeal carcinoma using Nituzumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of Nituzumab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), in combination with induction chemotherapy for patients with locally advanced nasopharyngeal carcinoma. The study aims to improve treatment outcomes by enhancing the effectiveness of radiotherapy and reducing the rates of local recurrence and distant metastasis. Participants will receive either Nituzumab or a placebo in a randomized, double-blind manner, allowing for a robust comparison of treatment effects. The trial is designed to assess the overall survival and response rates of patients undergoing this combined treatment approach.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Voluntarily participate and sign the informed consent in writing.
2. Age: 18-70 years old, gender is not limited.
3. Nasopharynx squamous cell carcinoma diagnosed by histopathology.
4. Nasopharyngeal carcinoma 2018 AJCC (Eighth Edition) staging: t2-4n2m0 (metastatic lymph nodes have one of the following risk factors: the shortest length of the largest lymph node is ≥ 3cm or the lymph node is liquefied and necrotic or the lymph node envelope is invaded) or t1-4n3m0.
5. Immunohistochemistry: EGFR (+).
6. The primary tumor can be measured.
7. Kaplan score \> 70.
8. Survival expectation ≥ 6 months.
9. Women in childbearing period should ensure to take effective contraception during the study period.
10. Hemoglobin (Hgb) ≥ 90 g / L, white blood cell (WBC) ≥ 4 × 109 / L, platelet (PLT) ≥ 90 × 109 /L.
11. Liver function: ALT and / or ast \< 1.5 times the upper limit of normal value (ULN), and TBIL \< 1.5 times the upper limit of normal value (ULN).

Renal function: serum creatinine \< 1.5 times the upper limit of normal value (ULN); Creatinine clearance rate shall not be lower than 60ml / min.

Exclusion criteria：

1. There is evidence of distant metastasis.
2. The primary tumor or lymph node has been treated surgically (except biopsy).
3. Patients with primary focus or lymph nodes who have received radiotherapy.
4. Those who have received epidermal growth factor targeted therapy.
5. The primary lesion has received chemotherapy or immunotherapy.
6. Have had other malignant tumors (except non melanoma skin cancer or cervical carcinoma in situ).
7. Subjects who have received other drug tests in the past 1 month.
8. \> grade I peripheral neuropathy.
9. Pregnant or lactating women and women of childbearing age who refuse contraception during the treatment observation period.
10. Those with severe allergic history or special constitution.
11. A history of severe lung or heart disease.
12. Known to be infected with HIV virus or active viral hepatitis.
13. Received live vaccine within 30 days of the planned start of study drug treatment.
14. Those who refuse or cannot sign the informed consent form.
15. Drug or alcohol addicts.
16. Persons with personality or mental illness, without or with limited capacity for civil conduct.

Where it's running

• Sichuan Cancer Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: MEI FENG, doctor — 四川省肿瘤研究所
• Study coordinator: MEI FENG, doctor
• Email: freda_fm@126.com
• Phone: 13076000700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.