Design of the study and its participants
tumor, acquired immunodeficiency diseases, swallow disability, infection, mental disorders
TUMOR, RECURRENCE, METASTASIS, HEART DISEASE, AUTOIMMUNE DISEASES, INFECTION, SOLID TUMOR, ONCOLOGY, PATHOLOGY, DISEASES
This was a multicenter, open-label, single-arm, phase II clinical trial conducted at five hospitals in Guangxi, China, where the morbidity and mortality of NPC is high.(Inclusion criteria: (1) Male or female patients: 18–70 years old; (2) patients with NPC confirmed by pathology; (3) local recurrence and/or distant metastasis after one comprehensive treatment, and progression following at least first-line treatment; (4) Eastern Cooperative Oncology Group (ECOG) physical status score: 0–1; (5) at least one measurable lesion evaluated using Response Evaluation Criteria in Solid Tumor sversion1.1 (RECIST1.1); (6) expected survival ≥ 6 months; (7) the body’s major organs are functioning well; and (8) with satisfactory compliance and follow-up, the subjects willingly participated in the study and completed an informed consent form. The exclusion criteria were as follows: current autoimmune illnesses or a history of autoimmune diseases; diseases requiring immunosuppressive drugs, including congenital or acquired immunodeficiency diseases, active hepatitis B or C virus infection, active infection or uncontrollable heart disease; invaded important blood vessels by tumor; swallow disability; mental disorders; pregnancy; and prior anti-PD-L1 or anti-PD-1 antibody therapy.