RecruitingPhase 2NCT05508347

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

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


Sponsor

Sichuan Cancer Hospital and Research Institute

Enrollment

170 participants

Start Date

Apr 20, 2022

Study Type

INTERVENTIONAL

Conditions

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 ®)。


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an antibody drug called nimotuzumab (Taixinsheng) to standard chemotherapy improves outcomes for patients with locally advanced nasopharyngeal carcinoma — a type of head and neck cancer that starts behind the nose. It is a randomized, placebo-controlled trial, meaning some participants receive the drug and some receive a placebo (inactive treatment). **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with nasopharyngeal carcinoma confirmed by tissue biopsy - Your cancer is locally advanced (stage T2-4, N2, M0 — meaning it has spread to nearby lymph nodes but not to distant organs) - You have not received prior treatment for this cancer - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have received prior chemotherapy or radiation for this cancer - You have serious liver, kidney, or heart conditions - You are pregnant or breastfeeding - You have an active autoimmune condition or are taking immune-suppressing drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNituzumab/placebo

Test group: 3 cycles of induction chemotherapy combined with 9 times of nituzumab targeted therapy followed by 2-3 cycles of synchronous radiotherapy and chemotherapy combined with 7 times of nituzumab targeted therapy, a total of 16 times of nituzumab targeted therapy, equivalent to the whole course targeted therapy. Control group: 3 cycles of induction chemotherapy combined with 9 times of placebo treatment followed by 2-3 cycles of concurrent chemoradiotherapy combined with 7 times of nituzumab targeted therapy, a total of 7 times of nituzumab targeted therapy, only targeted therapy during concurrent chemoradiotherapy


Locations(1)

Sichuan Cancer Hospital

Chengdu, Sichuan, China

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NCT05508347


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