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Adebrelimab Plus Temozolomide ± Hyperbaric Oxygen for Primary Glioblastoma
Sponsor: Wei Jiang
Summary
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.
Official title: A Prospective, Randomized, Open-Label, Multicenter Phase II Study of Adebrelimab Combined With Temozolomide With or Without Hyperbaric Oxygen Therapy for Newly-Diagnosed Primary Glioblastoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2026-10-01
Completion Date
2029-10-01
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Adebrelimab
1200 mg intravenous infusion on Day2 of each 28-day cycle, up to 12 months.
Temozolomide
Oral, Cycle 1:150 mg/m² d2-d6; Cycle 2-12: 200 mg/m² d2-d6, q28d; minimum 6 cycles, maximum12 cycles.
Procedure:Hyperbaric Oxygen Therapy
2ATA absolute pressure, 90 minutes once daily, Day1-7 per 28-day cycle. Adebrelimab infusion shall be completed within 24 hours after HBOT.