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NOT YET RECRUITING
NCT07789379
PHASE2

Adebrelimab Plus Temozolomide ± Hyperbaric Oxygen for Primary Glioblastoma

Sponsor: Wei Jiang

View on ClinicalTrials.gov

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

DRUG

Adebrelimab

1200 mg intravenous infusion on Day2 of each 28-day cycle, up to 12 months.

DRUG

Temozolomide

Oral, Cycle 1:150 mg/m² d2-d6; Cycle 2-12: 200 mg/m² d2-d6, q28d; minimum 6 cycles, maximum12 cycles.

PROCEDURE

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.