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 Loc

• Status: Recruiting
• Trial end date: 2023-09-15
• Target enrollment: 0
• Participant gender: All

Summary

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 ®）。

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Cancer Hospital and Research Institute

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.