🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 3Ages 18 Years - 70 YearsAllFudan University
NCT05772208 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+. 2. Age 18-70 years. 3. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer\[AJCC\] edition). 4. Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant. 5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L. 7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.0×ULN. 8. Renal function: serum creatinine \<1×ULN. 9. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: 1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I) 2. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. 3. Receiving radiotherapy or chemotherapy or targeted therapy previously 4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. 6. Severe, uncontrolled medical conditions and infections. 7. At the same time using other test drugs or in other clinical trials. 8. Refusal or inability to sign informed consent to participate in the trial. 9. Emotional disturbance or mental
💊

What it tests

  • Camrelizumab
  • Nimotuzumab
  • neoadjuvant chemotherapy and CCRT
📍

Where

1 site
Fudan Universtiy Shanghai Cancer Centre
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy