Toripalimab vs. Placebo Wtih GP Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Recruiting
Phase 3
Interventional Study
Nasopharyngeal Carcinoma (NPC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 466 (estimated)
- Sponsor
- Sun Yat-sen University · Other
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About This Trial
The main questions it aims to answer are:
1. Does the combination of GP induction chemotherapy and toripalimab improve the 3-year progression-free survival (PFS) compared to GP induction chemotherapy with placebo?
2. What are the differences in CR after induction therapy, 3-year overall survival (OS), locoregional progression, and distant progression between the two groups?
3. What are the differ…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Voluntarily participates and signs an informed consent form.
2. Aged 18-70 years, male or non-pregnant female.
3. Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
4. Staging of any T, N2-3 or T4…
Contacts