Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC

Inclusion Criteria:

1. Male or female; 18-70 years of age;
2. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th;the metastatic tissue biopsy is preferred, not necessary; locoregional recurrentlesion unfit for local treatment).
3. Did not receive any systemic treatment for recurrent and metastatic lesions. (Previousradiotherapy, induction chemotherapy, concurrent chemoradiotherapy, or adjuvantchemotherapy should have been completed at least 6 months prior to treatment)
4. ECOG performance status of 0 or 1.
5. Subjects enrolled must have measurable lesion(s) according to response evaluationcriteria in solid (RECIST) v1.1.
6. Adequate organ function assessed by laboratory parameters during the screening period
7. Life expectancy more than 12 weeks.
8. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

1. Patients with a high risk of nasopharyngeal necrosis: ① Patients with recurrent stageT3-4 received two courses of radiotherapy before enrollment, or receivednasopharyngeal radiotherapy within 1 year before enrollment; ② Patients with recurrentT1-2 stage had received two courses of nasopharyngeal radiotherapy and the lastradiotherapy within 1 year before enrollment.
2. Patients with other malignancies (except for cervical cancer, basal cell carcinoma orsquamous cell carcinoma of the skin, localized prostate cancer, and ductal carcinomain situ who have undergone curative treatment).
3. Special attention: Patients with active bleeding, ulcers, bowel perforations, andmajor surgery within 30 days; tumors in close proximity to the internal carotid arteryor other major vessels, and those at risk of major bleeding. Patients with or previouswith serious hemorrhage (bleeding >30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/ortransient ischemic attack).
4. Patients with hypertension who cannot be reduced to the normal range byantihypertensive drug treatment (systolic blood pressure > 140 mmHg/diastolic bloodpressure > 90 mmHg), patients with ≥ grade II coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms in men and > 470 ms in women) andcardiac insufficiency.
5. Patients with known or suspected autoimmune diseases including dementia and seizures.
6. Multiple factors affecting the absorption of oral medications (e.g., dysphagia,chronic diarrhea, and bowel obstruction).
7. An excessive dose of glucocorticoids given within 4 weeks before enrollment.
8. Complications requiring long-term use of immunosuppressive drugs or systemic or localuse of immunosuppressive-dose corticosteroids.
9. HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibodypositive).
10. Women of childbearing age with a positive pregnancy test and lactating women.