About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- EGFR Antibody
- PD-1 antibody
- Gemcitabine, Cisplatin
- IMRT
Treatment groups
Sponsors and collaborators
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