At a glance
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NCT04778956Phase 3RecruitingUpdate OverdueUpdated 63mo ago · Completion was 15mo agoToripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Toripalimab and salvage surgery for Nasopharyngeal Carcinoma and 2 related conditions. Currently recruiting, targeting 218 participants across 7 sites.
Signals
Detailed Summary
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Study Details
Timeline
Interventions
Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.