Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma
Status:
Not yet recruiting
Trial end date:
2027-05-01
Target enrollment:
Participant gender:
Summary
The goal of this phase II randomized clinical trial is to compare the safety and efficacy of
Elemene plus Stupp Protocol (the new protocol) and Stupp Protocol alone (the standard
protocol) in patients with newly-diagnosed glioblastomas (ndGBMs). The main questions to
answer are:
- Whether the new treatment protocol (Elemene plus Stupp Protocol) is clinically safe for
ndGBM patients.
- Whether the new treatment protocol (Elemene plus Stupp Protocol) brings better survival
benefits for ndGBM patients compared to the standard-of-care Stupp Protocol.
Study participants will be enrolled in 5 hospitals in China and randomly assigned to receive
either the new protocol or the standard protocol. The overall survival (OS) rate in the 12th
month, the progression-free survival (PFS) rate in the 6th month, OS, PFS, and adverse events
assessed by the CTCAE (Common Terminology Criteria for Adverse Events) will be evaluated for
all patients.