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
Overview
- Phase
- Phase 3
- Intervention
- Camrelizumab
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Fudan University
- Enrollment
- 459
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Chaosu Hu
MD and PhD
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+.
- •Age 18-70 years.
- •Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer\[AJCC\] edition).
- •Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant.
- •ECOG (Eastern Cooperative Oncology Group) score: 0-1
- •Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
- •Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.0×ULN.
- •Renal function: serum creatinine \<1×ULN.
- •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
- •Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- •Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- •Receiving radiotherapy or chemotherapy or targeted therapy previously
- •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.
- •Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- •Severe, uncontrolled medical conditions and infections.
- •At the same time using other test drugs or in other clinical trials.
- •Refusal or inability to sign informed consent to participate in the trial.
- •Emotional disturbance or mental
Arms & Interventions
the combination of camrelizumab and standard treatment
camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.
Intervention: Camrelizumab
the combination of camrelizumab and standard treatment
camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.
Intervention: neoadjuvant chemotherapy and CCRT
the combination of nimotuzumab and standard treatment
nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.
Intervention: Nimotuzumab
the combination of nimotuzumab and standard treatment
nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.
Intervention: neoadjuvant chemotherapy and CCRT
standard treatment
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.
Intervention: neoadjuvant chemotherapy and CCRT
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 3 years
Defined from date of randomization to date of first documentation of progression or death due to any cause
Secondary Outcomes
- Overall survival(3 years)
- Toxicities(3 years)