Adebrelimab Plus Temozolomide ± Hyperbaric Oxygen for Primary Glioblastoma

Conditions

• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Adebrelimab — DRUG
  1200 mg intravenous infusion on Day2 of each 28-day cycle, up to 12 months.
• Temozolomide — DRUG
  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 — PROCEDURE
  2ATA absolute pressure, 90 minutes once daily, Day1-7 per 28-day cycle. Adebrelimab infusion shall be completed within 24 hours after HBOT.

Study Details

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.

Key Dates

First listed

Aug 27, 2026

Start date

Oct 1, 2026

Status verified

Aug 2026

Primary completion

Oct 1, 2028

Completion

Oct 1, 2029

Study Design

Enrollment

94 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Adebrelimab + Temozolomide + Hyperbaric Oxygen Therapy
• Active Comparator: Arm B
  Adebrelimab + Temozolomide

Primary Outcome Measure

Progression-Free Survival (PFS) [ 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. ]

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