GlioblastomaPhase 2NCT07789379
Adebrelimab Plus Temozolomide ± Hyperbaric Oxygen for Primary Glioblastoma
A Phase 2 study testing Adebrelimab, Temozolomide and Procedure:Hyperbaric Oxygen Therapy in people with Glioblastoma, run by Wei Jiang.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Adebrelimab, Temozolomide and Procedure:Hyperbaric Oxygen Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
- Being tested
- Adebrelimab, Temozolomide, Procedure:Hyperbaric Oxygen Therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
1200 mg intravenous infusion on Day2 of each 28-day cycle, up to 12 months.
TemozolomideDrug
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 TherapyProcedure or surgery
2ATA absolute pressure, 90 minutes once daily, Day1-7 per 28-day cycle. Adebrelimab infusion shall be completed within 24 hours after HBOT.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Adebrelimab + Temozolomide + Hyperbaric Oxygen Therapy Receives: Drug: Adebrelimab; Drug: Temozolomide; Procedure: Procedure:Hyperbaric Oxygen Therapy |
| Arm B | Active comparator | Adebrelimab + Temozolomide Receives: Drug: Adebrelimab; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Time from first study treatment to death of any cause. Surviving subjects are censored at date of last survival follow-up.
Measured: 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)
Percentage of participants achieving Complete Response (CR) or Partial Response (PR) assessed by iRANO criteria. CR/PR need confirmation ≥4 weeks later.
Measured: 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)
Percentage of participants achieving CR, PR or Stable Disease (SD) assessed by iRANO criteria.
Measured: 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
Incidence, grade, causality and resolution of TRAE, irAE, SAE.
Measured: From date of signed informed consent through 90-days after last study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Jiang, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789379
- Sponsor's protocol ID
- TJFCH-2026-210
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07789379
- Acronym / sponsor ID
- TJFCH-2026-210
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Wei JiangUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Adebrelimab, Drug: Temozolomide, Procedure: Procedure:Hyperbaric Oxygen TherapyAdebrelimab + Temozolomide + Hyperbaric Oxygen Therapy |
| Arm B | Active comparator | Drug: Adebrelimab, Drug: TemozolomideAdebrelimab + Temozolomide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebrelimab1200 mg intravenous infusion on Day2 of each 28-day cycle, up to 12 months. | Drug | Arm A, Arm B |
| TemozolomideOral, Cycle 1:150 mg/m² d2-d6; Cycle 2-12: 200 mg/m² d2-d6, q28d; minimum 6 cycles, maximum12 cycles. | Drug | Arm A, Arm B |
| Procedure:Hyperbaric Oxygen Therapy2ATA absolute pressure, 90 minutes once daily, Day1-7 per 28-day cycle. Adebrelimab infusion shall be completed within 24 hours after HBOT. | Procedure or surgery | Arm A |
Primary outcome
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.
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From date of signed informed consent through 90-days after last study drug administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Temozolomide and Procedure:Hyperbaric Oxygen Therapy in people with Glioblastoma, run by Wei Jiang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.