Efficacy and Safety of Sintilimab Plus Bevacizumab in Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: An Open-label Phase II Study

PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab for Patients With Metastatic Nasopharyngeal Carcinoma After Failure of Platinum-based Chemotherapy: A Single Center, Single Arm, Phase II Clinical Study.

To evaluate the efficacy and safety of PD-1 immune checkpoint inhibitor combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy.

To evaluate the efficacy and safety of sintilimab combined with bevacizumab in the treatment of metastatic nasopharyngeal carcinoma (NPC) after platinum-based chemotherapy failure. The primary end point is objective response rate (ORR), the secondary end points are overall survival (OS), progression-free survival (PFS), duration of response (DOR), adverse effects and quality of life.

Inclusion Criteria:

• Patients diagnosed with metastatic nasopharyngeal carcinoma are not suitable for radical local treatment.
• Previous failure of first-line platinum-containing chemotherapy (single drug or combination).
• Previously diagnosed WHO classification type II or III by histological pathology.
• At least one measurable lesion (according to RECIST1.1).
• Age between 18 and 70.
• Eastern Cooperative Oncology Group (ECOG) 0-1, and life expectation at least 3 months.
• Enough blood test.
• Participate voluntarily and sign the informed consent.

Exclusion Criteria:

• Previously diagnosed WHO classification type I by histological pathology.
• Prior exposure to anti-PD-1/PD-L1 antibodies plus anti-VEGF antibodies.
• Necrotizing lesions were found within the first 4 weeks, or the risk of massive bleeding.
• A history of interstitial pneumonia or other autoimmune diseases.
• Sever infection.
• Sever heart disease.
• HIV infection.
• Allogeneic organ transplantation
• Malignancy other than nasopharyngeal carcinoma.
• Pregnancy or breast feeding.
• Received other test drugs.