Treatment for locally advanced nasopharyngeal carcinoma using Nituzumab

Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China

This study is testing if adding a new drug called Nituzumab to standard chemotherapy can help people with locally advanced nasopharyngeal cancer live longer and have better treatment results.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sichuan Cancer Hospital and Research Institute (other)
• Drugs / interventions: chemotherapy, immunotherapy, nitumab, radiation, Nimotuzumab, cetuximab
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05508347 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed nasopharyngeal squamous cell carcinoma and specific staging criteria.

Not a fit: Patients with early-stage nasopharyngeal carcinoma or those without EGFR expression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and reduce recurrence in patients with locally advanced nasopharyngeal carcinoma.

How similar studies have performed: Previous studies have indicated that combining induction chemotherapy with anti-EGFR therapies may enhance treatment efficacy in similar patient populations.

Eligibility criteria

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 this trial is running

Chengdu, Sichuan

• 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

Conditions: Nasopharyngeal Carcinoma