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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    36
  • sponsor
    Sun Yat-sen University
Updated on 4 October 2022
carcinoma
chemotherapy regimen
nasopharyngeal carcinoma

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.

Details
Condition Locally Advanced Nasopharyngeal Carcinoma, Envafolimab, Induction Chemotherapy, PD-L1
Treatment Envafolimab Plus Chemoradiotherapy
Clinical Study IdentifierNCT05397769
SponsorSun Yat-sen University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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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