Adebrelimab Plus Temozolomide ± Hyperbaric Oxygen for Primary Glioblastoma

NCT07789379 | Not Yet Recruiting Phase 2

• 1 other identifier: TJFCH-2026-210
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (4)

• Overall Survival (OS)

  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)

  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)

  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

  From date of signed informed consent through 90-days after last study drug administration.

Study Arms (2)

Arm A

EXPERIMENTAL

Adebrelimab + Temozolomide + Hyperbaric Oxygen Therapy

Drug: Adebrelimab; Drug: Temozolomide; Procedure: Procedure:Hyperbaric Oxygen Therapy

Arm B

ACTIVE COMPARATOR

Adebrelimab + Temozolomide

Drug: Adebrelimab; Drug: Temozolomide

Interventions

Adebrelimab DRUG

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

Arm A; Arm B

Temozolomide DRUG

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

Arm A; Arm B

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.

Arm A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years, male or female.
• Newly-diagnosed primary glioblastoma histologically-confirmed; received maximal safe resection or biopsy, and completed standard concurrent chemoradiotherapy with temozolomide.
• Dexamethasone dose ≤4 mg/day at initiation of adjuvant study treatment.
• Karnofsky Performance Status(KPS) ≥70.
• Expected survival ≥3 months.
• Adequate bone marrow: ANC ≥1.5×10\^9/L; Hb ≥90 g/dL; PLT ≥100×10\^9/L; WBC ≥3.0×10\^9/L.
• Adequate liver function: ALT/AST/ALP ≤2.5×ULN (≤5×ULN if liver metastasis); total bilirubin \<1.5×ULN.
• Adequate coagulation function: PT, APTT, INR ≤1.5×ULN.
• Female not pregnant / lactating; effective contraception required for fertile females and males during study and 6-month after last study treatment.
• Signed written informed consent, willing to comply with study procedures.
• Not participating in other interventional clinical trials.

You may not qualify if:

• Prior anti-angiogenic, targeted, immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, CTLA-4 antibody etc.).
• Progressive disease according to iRANO criteria. Suspicious pseudo-progression should be further evaluated by advanced imaging.
• Multifocal glioblastoma (separate tumor lesions without overlapping T2/FLAIR signal), or leptomeningeal metastasis.
• Prior interstitial brachytherapy, implanted chemotherapy, local injection, convection-enhanced delivery; prior Gliadel wafer placement; prior Optune device usage.
• Tumor completely located in infratentorial region.
• Known hypersensitivity to temozolomide or adebrelimab components.
• Dexamethasone \>4 mg/day at adjuvant treatment initiation.
• History of immunodeficiency, or receiving immunosuppressive agents within 7 days before first study drug (except dexamethasone ≤4 mg daily).
• Uncontrolled concurrent severe disease: active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, uncontrolled hypertension or psychiatric condition interfering with study compliance.
• Active systemic autoimmune disease requiring systemic therapy within past 2 years; physiological replacement therapy (thyroxine, insulin etc.) are allowed.
• Medical conditions unsuitable for hyperbaric oxygen therapy or immunotherapy.
• Severe anemia or concomitant medications interfering temozolomide absorption.
• Uncontrolled major psychiatric disorder including depression with CESD-R score ≥16.
• Cognitive impairment preventing neuro-oncology assessment.
• Pregnant or lactating women.

Sponsors & Collaborators

• Wei Jiang: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief Physician, Department of Radiation Oncology

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share