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Trial Title:
Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
NCT ID:
NCT05772208
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Nimotuzumab
Conditions: Keywords:
EBV DNA
camrelizumab
nimotuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
camrelizumab 200mg q3w
Arm group label:
the combination of camrelizumab and standard treatment
Intervention type:
Drug
Intervention name:
Nimotuzumab
Description:
nimotuzumab 200mg qw
Arm group label:
the combination of nimotuzumab and standard treatment
Intervention type:
Drug
Intervention name:
neoadjuvant chemotherapy and CCRT
Description:
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.
Arm group label:
standard treatment
Arm group label:
the combination of camrelizumab and standard treatment
Arm group label:
the combination of nimotuzumab and standard treatment
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan Universtiy Shanghai Cancer Centre
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Ying, M.D.
Phone:
+8621-64175590
Phone ext:
81400
Email:
yinghongmei2011@sina.com
Start date:
January 1, 2022
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05772208
