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

RecruitingPhase 2Ages 18 Years - 65 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Envafolimab Plus Chemoradiotherapy
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Where

1 site
Sun Yat-sen University Cancer Center
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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