This is a prospective, randomized, open-label, multicenter phase II study. Newly-diagnosed primary glioblastoma patients who have undergone maximal safe resection or biopsy and completed standard concurrent chemoradiotherapy will be enrolled. Subjects will be randomized 1:1 into Arm A (Adebrelimab + Temozolomide + Hyperbaric Oxygen Therapy) or Arm B (Adebrelimab + Temozolomide). The primary endpoint is progression-free survival(PFS). Secondary endpoints include overall survival(OS), objective response rate(ORR), disease control rate(DCR), change of KPS score, safety including TRAE, irAE and SAE. Exploratory objectives include correlation analysis between baseline clinical characteristics / hyperbaric-oxygen-related biomarkers and efficacy-safety outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
1200 mg intravenous infusion on Day2 of each 28-day cycle, up to 12 months.
Oral, Cycle 1:150 mg/m² d2-d6; Cycle 2-12: 200 mg/m² d2-d6, q28d; minimum 6 cycles, maximum12 cycles.
2ATA absolute pressure, 90 minutes once daily, Day1-7 per 28-day cycle. Adebrelimab infusion shall be completed within 24 hours after HBOT.
Progression-Free Survival (PFS)
Time from first study treatment to disease progression (per iRANO criteria) or death from any cause, whichever occurs first. Subjects without progression/death will be censored at last valid tumor assessment.
Time frame: From first study treatment, tumor imaging performed every 6-9 weeks (±7 days) for the first 24 weeks, then every 12 weeks (±7 days); assessed up to 24-months after first study treatment.
Overall Survival (OS)
Time from first study treatment to death of any cause. Surviving subjects are censored at date of last survival follow-up.
Time frame: From first study treatment; survival follow-up every 3 months (±28 days); assessed up to 24-months after first study treatment
Objective Response Rate (ORR)
Percentage of participants achieving Complete Response (CR) or Partial Response (PR) assessed by iRANO criteria. CR/PR need confirmation ≥4 weeks later.
Time frame: Baseline; tumor imaging every 6-9 weeks (±7 days) for first 24 weeks, then every 12 weeks (±7 days); assessed up to 24-months after first study treatment.
Disease Control Rate (DCR)
Percentage of participants achieving CR, PR or Stable Disease (SD) assessed by iRANO criteria.
Time frame: Baseline, Day1 of each 28-day treatment cycle, End-of-Treatment visit, follow-up visits; assessed up to 24-months after first study treatment.
hange from Baseline in Karnofsky Performance Status (KPS) score
Incidence, grade, causality and resolution of TRAE, irAE, SAE.
Time frame: From date of signed informed consent through 90-days after last study drug administration.
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