Nasopharyngeal Carcinoma
Conditions
Keywords
EBV DNA, camrelizumab, nimotuzumab
Brief 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.
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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years | Defined from date of randomization to date of first documentation of progression or death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up. |
| Toxicities | 3 years | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. |
Countries
China
Contacts
Primary ContactChengrun Du
Outcome results
None listed