Actively Recruiting
Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
Led by Fudan University · Updated on 2023-03-16
459
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type WHO II or III, EGFR positive
- Age between 18 and 70 years
- Clinical stage III-IVa according to 8th AJCC edition
- Detectable plasma EBV DNA before treatment and remaining detectable after one cycle of neoadjuvant chemotherapy
- ECOG performance score of 0 or 1
- Hemoglobin level of at least 90 g/L, white blood cell count of at least 4 x 10^9/L, and platelet count of at least 100 x 10^9/L
- Liver function tests (ALT and AST) less than 1.5 times upper limit of normal, total bilirubin less than 1.0 times upper limit of normal
- Normal renal function with serum creatinine less than upper limit of normal
- Signed informed consent and willingness to comply with study visits, treatments, laboratory tests, and research requirements
You will not qualify if you...
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- History of other malignant tumors except cured basal cell carcinoma or cervical carcinoma in situ
- Previous radiotherapy, chemotherapy, or targeted therapy
- Pregnant or breastfeeding women of child-bearing potential
- Significantly impaired heart, liver, lung, kidney, or bone marrow function
- Severe uncontrolled medical conditions or infections
- Use of other experimental drugs or participation in other clinical trials
- Refusal or inability to provide informed consent
- Emotional disturbance or mental health conditions preventing participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Chengrun Du
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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