Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.
Recruiting
Phase 2
Interventional Study
Locally Advanced Nasopharyngeal Carcinoma
Envafolimab
Induction Chemotherapy
PD-L1
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- Sun Yat-sen University · Other
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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+En…
Trial Locations
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Eligibility 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 ≤ …
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