Can oxygen therapy boost immunotherapy against brain cancer?
NCT ID NCT07789379
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial tests whether adding hyperbaric oxygen therapy to a standard immunotherapy-chemotherapy combination can help people with newly diagnosed glioblastoma. Participants receive either adebrelimab plus temozolomide alone, or the same drugs with hyperbaric oxygen sessions. The study measures how long people live without the cancer progressing, overall survival, and safety. It enrolls adults aged 18 to 70 who have completed standard chemoradiotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adebrelimab (an immunotherapy drug) combined with temozolomide (a chemotherapy drug), with or without hyperbaric oxygen therapy
- What this could lead to
- If it works, this could point toward a more effective first-line treatment for glioblastoma, potentially slowing tumor growth and extending survival.
- What could go wrong
- This is a phase II trial with a relatively small number of participants, so results may not hold up in larger studies. Adding hyperbaric oxygen and immunotherapy may also increase side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Participated in other relevant clinical trials within prior 3 months. * Life-threatening complication or vegetative state after chemoradiotherapy. * Other malignant tumor within past 5 years (except cured carcinoma in-situ, basal-cell skin carcinoma). Poor compliance unable to follow protocol. * Substance-use disorder (DSM-V criteria: alcohol or drug addiction). * Active cardiac disease within 6 months prior to screening: myocardial infarction, unstable angina; LVEF\<50%, poorly controlled arrhythmia. * Active infection or unexplained fever\>38.5℃ at screening / before first dosing (fever attributed to tumor is permitted). * Immunodeficiency including active hepatitis; HBV-DNA ≥1000 IU/ml; HCV-RNA ≥1000 IU/ml. Chronic HBV carrier with HBV-DNA\<2000 IU/ml must receive concurrent antiviral treatment to be eligible. * Investigator's judgment that subject is inappropriate for this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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