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BCG is the most effective method for treating high-risk non-muscular impregnated bladder cancer.
Nadfaragene firadenovec (also known as rAd-IFNa/Syn3) is a recombinative adenovirus that transfects human interferon α-2b cDNA into bladder epithelial cells and is a new in-bladder therapy for BCG's non-reactive non-muscular-immersive bladder cancer.
study aims to assess the efficacy of Nodfaragene firadenovec for BCG non-reactive non-muscular-immersive bladder cancer.
the trial was a multi-center, open-label, repetitive phase 3 trial that recruited 18-year-old BCG non-reactive non-muscular-immersive bladder cancer patients and injected 75 mL of Nadofaragene firadenovec (3×1011 virus particles/mL) into the bladder.
is repeated at 3, 6 and 9 months.
end of the disease is the total remission rate of in-place cancer patients.
assumes that the queue has a full response rate of less than 27%.
September 19, 2016 - May 24, 2019, 198 patients were screened, 41 patients were excluded, and 157 patients were included in the study for at least one dose of the study.
6 patients were excluded from BCG's non-reactive non-muscular leaching bladder cancer definition;
55 (53.4%) of the 103 in-place cancer patients (with or without high-level Stage Ta or T1 tumors) received complete remission within 3 months of the application of dose 1 treatment, of which 25 (45.5%) had a remission period that lasted until the 12th month.
drug-related adverse reactions to the 3-4 level study were urgency of urination (2 cases, both level 3).
treatment-related deaths.
not only in the bladder, It is effective and has significant benefits for BCG's non-reactive non-muscular-immersive bladder cancer.
this represents a new treatment option.
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