EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

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

148 Participants
are divided into 1 treatment group

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