This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Patients with nasopharyngeal carcinoma who have recurred/metastasized after initial treatment or radical treatment;
Age 18-75, male or female;
Pathological diagnosis of nasopharyngeal carcinoma;
ECOG score 0-1;
Patients with recurrence who can be treated with local resection or radiotherapy;
Known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies;
Patients have symptoms of central nervous system metastasis such as brain edema and need hormonal intervention;
Had an active infection or unexplained fever >38.5℃ during screening or prior to the first dose (the investigator determined that the subject's fever due to the tumor could be enrolled);
Single group
EGFR Antibody
Drug6 cycles for combined therapy. Maintenance for 1 year.
PD-1 antibody
Drug6 cycles for combined therapy. Maintenance for 1 year.
Gemcitabine, Cisplatin
Drug6 cycles for combined therapy.
IMRT
RadiationIMRT for primary lesion
Progression-free survival (PFS)
From the date of recruiting to the first occurrence of disease progression as determined according to RECIST v1.1 or death from any cause, whichever occurs first.
Adverse events
All adverse event or serious adverse event that occurred during the study period according to CTCAE v 5.0.
Overall survival (OS)
From the date of recruiting to the date of death from any cause.
Objective response rate (ORR)
The percentage of patients with CR and PR assessed according to RECIST v1.1.
Disease control rate (DCR)
The proportion of patients who have achieved complete response, partial response and stable disease according to RECIST v1.1.
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Sun Yat-sen University
Lead sponsor
Zhejiang Cancer Hospital
Collaborator
Wuhan TongJi Hospital
Collaborator
Xijing hospital of The fourth military medical university
Collaborator
Dongguan People's Hospital
Collaborator
Liuzhou Workers' Hospital
Collaborator
Chongqing University Cancer Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
Fujian Province Tumor Hospital
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
