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

Launched by SICHUAN CANCER HOSPITAL AND RESEARCH INSTITUTE · Aug 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced nasopharyngeal carcinoma (NPC), a type of cancer found in the area behind the nose. The trial is looking at how effective and safe a drug called Nituzumab is when combined with chemotherapy and radiation therapy compared to radiation therapy alone. The goal is to see if this combination can improve survival rates and reduce the chances of the cancer coming back or spreading to other parts of the body.

To be eligible for this trial, participants need to be between 18 and 70 years old and have a specific type of NPC diagnosed by a doctor. They should also have measurable tumors and meet certain health criteria, such as having good blood counts and liver and kidney function. Participants will receive the study treatment and will be closely monitored by healthcare professionals throughout the trial. This is an important study because it aims to find better ways to treat NPC and improve outcomes for patients facing this challenging diagnosis.

Gender

ALL

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.