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ABSTRACT: Background
This randomized, open-label, multicenter, phase II clinical trial was conducted to assess the anti-tumor efficacy and safety of replication-deficient adenovirus mutant thymidine kinase (ADV-TK) in combination with ganciclovir administration in patients with recurrent high-grade glioma (HGG).Patients and methods
53 patients with recurrent HGG were randomly allocated to receive intra-arterial cerebral infusion of ADV-TK or conventional treatments. The primary end point was 6-month progression-free survival (PFS-6). Secondary end points included progression-free survival (PFS), overall survival (OS), safety, and clinical benefit. This trial is registered with Clinicaltrials.gov, NCT00870181.Results
In ADV-TK group, PFS-6 was 54.5%, the median PFS was 29.6 we
SUBMITTER: Ji N
PROVIDER: S-EPMC4826211 | biostudies-literature | 2016 Jan
REPOSITORIES: biostudies-literature