RecruitingPhase 3NCT05772208

Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

A Multicenter, Randomized Controlled Phase III Trial of Induction Plus Concurrent Chemoradiotherapy Plus Camrelizumab or Nimotuzumab Versus Induction Plus Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

Sponsor

Fudan University

Enrollment

459 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma

Summary

The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying more intensive treatment for people with nasopharyngeal carcinoma (a type of head and neck cancer) whose virus-related genetic marker (EBV DNA) remains detectable in their blood after the first round of chemotherapy. This suggests the cancer may be harder to treat, so researchers are testing whether adding extra treatments can improve outcomes. **You may be eligible if...** - You have newly diagnosed nasopharyngeal carcinoma (WHO type II or III, EGFR-positive) - You are between 18 and 70 years old - Your cancer is stage III or IVa - Your EBV DNA level was detectable before treatment and is still detectable after the first cycle of chemotherapy - You have adequate blood counts and organ function **You may NOT be eligible if...** - Your EBV DNA became undetectable after the first chemotherapy cycle - You have poor organ function (liver, kidney, heart) - You have been treated for this cancer before 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

DRUGCamrelizumab

camrelizumab 200mg q3w

DRUGNimotuzumab

nimotuzumab 200mg qw

DRUGneoadjuvant chemotherapy and CCRT

the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.