Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC
Recruiting
Phase 3
Interventional Study
Nasopharyngeal Carcinoma
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 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 244 (estimated)
- Sponsor
- Sun Yat-sen University · Other
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About This Trial
This study aims to explore a new, more effective and tolerable treatment regimen for patients with advanced recurrent/metastatic nasopharyngeal carcinoma. Specifically, we plan to conduct a phase III randomized controlled clinical trial based on the standard treatment of "GP + PD-1 mAb", replacing cisplatin with apatinib to achieve "platinum-free" therapy and reduce toxicity. In addition, we will …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female; 18-70 years of age;
2. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary; locoregional recurrent lesion unfit for local treatment).
3. Did not receive any systemic tr…
Contacts
No contact information available.