Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.

Inclusion criteria

• ECOG 0-1
• histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx
• stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients
• NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
• ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
• creatinine<1.5×ULN

Exclusion criteria

• recurrent or metastatic NPC patients
• histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx
• already received radiation or chemotherapy
• pregnant or lactating women, or women of childbearing age without birth control
• HIV (+)
• had other cancers before
• used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before
• complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose
• with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included)
• use of massive dose of glucocorticoids within 4 weeks before enrollment
• laboratory test values do not meet relevant standards within 7 days before enrollment
• significantly lower functions of heart, liver, lung, kidney and bone marrow
• serious or uncontrolled medical diseases or infections
• participating other clinical trial in the same time
• HBsAg (+) and HBV DNA >1×10E3 copiers /mL
• HCV (+) unless HCV RNA PCR(-)
• with any other treatment contraindications