Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma

Inclusion Criteria:

1. Age ≥ 18 years and ≤75 years;
2. Subjects with histopathological diagnosis of nasopharyngeal carcinoma;
3. Primarily metastatic (stage IVB as defined by the International Union against Cancerand American Joint Committee on Cancer staging system for NPC, eighth edition) orrecurrent NPC that is not amenable for local regional treatment or curative treatment;
4. Has not received prior systemic treatment;
5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)Performance Status
6. Subject must have a measurable target lesion based on RECIST v1.1;

Exclusion Criteria:

1. Allergic to monoclonal antibodies, any camrelizumab components, gemcitabine, cisplatinand other platinum drugs;
2. Prior therapy as follow:

• Anti-PD-1 or anti-PD-L1;
• Received last dose of anticancer therapy (including chemotherapy, radiotherapy,targeted therapy, etc.) within 4 weeks of the first dose of study medication;
• Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisoneor equivalent dose) or other systematic immunosuppressive medications within 14days before the study treatment. Except: inhalation or topical corticosteroids.Doses > 10 mg/day prednisone or equivalent for replacement therapy;
• Received major operations or serious injuries within 4 weeks of the first dose ofstudy medication;

3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to apreviously anti-tumor treatment;
4. Pregnancy or breast feeding;