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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Envafolimab Plus Chemoradiotherapy

    Drug

    Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Envafolimab groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3-year progression free survival

time from the randomization to the first disease progression or death

Time frame
3-year

Secondary outcomes

Other outcomes

Sponsors and contacts

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