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

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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