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

Study Overview
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Brief Summary
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Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.

Official Title
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Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.

Conditions
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Envafolimab, Locally Advanced Nasopharyngeal Carcinoma, Induction Chemotherapy, PD-L1

Intervention / Treatment
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* Drug: Envafolimab Plus Chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Envafolimab group<br>Envafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy. | Drug: Envafolimab Plus Chemoradiotherapy<br>* Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression free survival | time from the randomization to the first disease progression or death | 3-year |