GlioblastomaPhase 2NCT07047066
A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma
A Phase 2 study testing Fluzoparib with Temozolomide in people with Glioblastoma, run by Tongji Hospital.
Trial summary
A Phase II clinical study is planned to evaluate the efficacy and safety of fluzoparib combined with temozolomide in newly diagnosed glioblastoma patients after completing standard concurrent chemoradiotherapy (CCRT), explore the effectiveness and safety of this regimen, and find a better treatment option for… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Fluzoparib with Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 31 Jul 2027
- 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
- 1.Signed informed consent form (ICF);
- 2. Age ≥18 years old, <70 years old;
- 3. Based on postoperative MRI, the total resection range is ≥80% compared with preoperative MRI (resection for the purpose of biopsy is not eligible);
- 4. Patients newly diagnosed with primary glioblastoma by imaging or pathology, completed concurrent chemoradiotherapy (CCRT), and planned to receive adjuvant TMZ treatment;
- 5. Appropriate hematological treatment and end-organ function within 14 days before randomization, defined by the following laboratory results:
- Absolute neutrophil count (ANC) ≥1.5×109/L;
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- Platelet count ≥100×109/L;
- Hemoglobin ≥90 g/L;
- Total bilirubin ≤1.5 ×ULN;
- AST and ALT ≤3 × ULN;
- Alkaline phosphatase ≤2.5 × ULN;
- Serum albumin ≥25 g/L;
- Serum creatinine ≤133 μmol/L;
- PT and aPTT ≤ 1.5 × ULN; 6. Karnofsky score ≥ 60; 7. Expected survival > 12 weeks; 8. Women of childbearing age*: must use highly effective contraceptive methods (resulting in a contraceptive failure rate of <1% per year) from the date of informed consent until at least 3 months after the last dose of the study drug fluzoparib/TMZ (whichever occurs later).
- Men: agree to use contraceptive measures, defined as follows: For female partners of childbearing potential or pregnant female partners, men must use highly effective contraceptive methods from the date of informed consent until at least 3 months after the last dose of the study drug fluzoparib/TMZ (whichever occurs later).
- Women are postmenopausal women who have not reached postmenopausal status (continuous amenorrhea for ≥ 12 months without a confirmed cause other than menopause) and have not undergone surgical sterilization (removal of the ovaries and/or uterus).
Who cannot join
- 1. During the concurrent chemoradiotherapy phase, the total radiotherapy dose is >60Gy; 2. Multifocal glioma (≥3 lesions); 3. Patients with primary infratentorial glioblastoma; 4. Patients with leptomeningeal disease; 5. Patients with stable or no dose reduction of corticosteroids within 14 days of randomization; 6. Pregnancy, lactation or breastfeeding (need to breastfeed or breastfeed during the study);
- Women of childbearing age (including women who have undergone tubal ligation) must undergo a blood pregnancy test 7. Major cardiovascular disease, including New York Heart Association heart disease (grade 2 or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia requiring treatment within the first 3 months, and/or newly diagnosed unstable angina; 8. Known clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, and hereditary liver disease; 9. Poorly controlled type 2 diabetes, defined as glycated hemoglobin ≥8% or fasting blood glucose ≥8.8 during the screening period mmol/L; 10. Major surgery (requiring general anesthesia) is expected during the study; 11. Any severe or uncontrollable systemic disease, including uncontrollable hypertension (defined as blood pressure still higher than 150/90 mmHg after effective antihypertensive treatment) and active bleeding disorders; 12. Any anticancer treatment after CCRT, whether experimental or approved, including chemotherapy, immunotherapy, gene therapy, cancer vaccine, cell therapy, cytokine/hormone therapy, and/or radiotherapy; 13. Persistent toxicity related to previous treatment (according to NCI CTCAE v5.0 toxicity level as > 1); according to the investigator's judgment, alopecia, sensory neuropathy ≤ 2, or other safety risk level ≤ 2 are eligible for inclusion; 14. Malignant tumors other than the study disease within 5 years before randomization, except for patients without risk of death or metastasis (adequately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer or ductal carcinoma in situ); 15. During the screening period, patients have active viral infections that require systemic treatment:
- HIV antibody positive;
- Active hepatitis B: defined as HBsAg positive or HBcAb positive, and HBV DNA test result > 2000 IU/mL;
- Active hepatitis C: defined as HCV antibody positive and PCR test HCV RNA positive. However, subjects with positive serum anti-HCV and negative HCV RNA can also be included;
- Syphilis infection (positive Treponema pallidum specific antibody); 16. Patients who the investigator believes are not suitable for participation in the trial or will violate the protocol
About this study
A Phase II clinical study is planned to evaluate the efficacy and safety of fluzoparib combined with temozolomide in newly diagnosed glioblastoma patients after completing standard concurrent chemoradiotherapy (CCRT), explore the effectiveness and safety of this regimen, and find a better treatment option for glioblastoma patients
- Conditions
- Glioblastoma
- Being tested
- Fluzoparib with Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzoparib with TemozolomideDrug
Fluzoparib: 100mg, po.bid. Q4W, d1-28, for a total of 6 cycles
Temozolomide (TMZ): 150-200 mg/m2, po. Q4W, d1-5, for a total of 6 cycles
If unacceptable toxicity occurs and a dose reduction is required, it is recommended to first reduce the dose from 100 mg (2 tablets) to 50 mg (1 tablet) twice a day. If further dose reduction is required, it is recommended to reduce the dose from 50 mg (1 tablet) twice a day to 50 mg (1 tablet) once a day. If it is still intolerable, the patient should withdraw from the clinical study.
The TMZ dose is adjusted by the investigator according to standard chemotherapy requirements. Adjuvant TMZ treatment of less than 6 cycles is allowed depending on the subject's condition (e.g. confirmed disease progression, intolerable toxicity, etc.). Tumor assessment is performed during two cycles of TMZ (q8w±7 days) during the study or when clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib combined with Temozolomide | Experimental | Not described Receives: Drug: Fluzoparib with Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Defined as the time from the date of randomization to death from any cause.
Measured: Patients were assessed up to 36 months from enrollment to first death (whichever occurred first)
Secondary outcomes (2)
PFS
PFS is defined as the time (in days) from the first use of study drug to the first observation of disease progression.
Measured: From enrollment to the first appearance of disease progression or date death from any cause,whichever came first,assessed up to 36 mounths
ORR
Objective response rate
Measured: From enrollment to initial efficacy evaluation ,assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangyuan Hu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047066
- Sponsor's protocol ID
- GBM-Ⅱ-001
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT07047066
- Acronym / sponsor ID
- GBM-Ⅱ-001
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 2 Jul 2025 (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.
A Phase II clinical study is planned to evaluate the efficacy and safety of fluzoparib combined with temozolomide in newly diagnosed glioblastoma patients after completing standard concurrent chemoradiotherapy (CCRT), explore the effectiveness and safety of this regimen, and find a better treatment option for glioblastoma patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib combined with Temozolomide | Experimental | Drug: Fluzoparib with Temozolomide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 1.Signed informed consent form (ICF);
- 2. Age ≥18 years old, <70 years old;
- 3. Based on postoperative MRI, the total resection range is ≥80% compared with preoperative MRI (resection for the purpose of biopsy is not eligible);
- 4. Patients newly diagnosed with primary glioblastoma by imaging or pathology, completed concurrent chemoradiotherapy (CCRT), and planned to receive adjuvant TMZ treatment;
- 5. Appropriate hematological treatment and end-organ function within 14 days before randomization, defined by the following laboratory results:
Key exclusion criteria (6 listed)
- 1. During the concurrent chemoradiotherapy phase, the total radiotherapy dose is >60Gy; 2. Multifocal glioma (≥3 lesions); 3. Patients with primary infratentorial glioblastoma; 4. Patients with leptomeningeal disease; 5. Patients with stable or no dose reduction of corticosteroids within 14 days of randomization; 6. Pregnancy, lactation or breastfeeding (need to breastfeed or breastfeed during the study);
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 |
|---|---|---|
| Fluzoparib with TemozolomideFluzoparib: 100mg, po.bid. Q4W, d1-28, for a total of 6 cycles Temozolomide (TMZ): 150-200 mg/m2, po. Q4W, d1-5, for a total of 6 cycles If unacceptable toxicity occurs and a dose reduction is required, it is recommended to first reduce the dose from 100 mg (2 tablets) to 50 mg (1 tablet) twice a day. If further dose reduction is required, it is recommended to reduce the dose from 50 mg (1 tablet) twice a day to 50 mg (1 tablet) once a day. If it is still intolerable, the patient should withdraw from the clinical study. The TMZ dose is adjusted by the investigator according to standard chemotherapy requirements. Adjuvant TMZ treatment of less than 6 cycles is allowed depending on the subject's condition (e.g. confirmed disease progression, intolerable toxicity, etc.). Tumor assessment is performed during two cycles of TMZ (q8w±7 days) during the study or when clinically indicated | Drug | Fluzoparib combined with Temozolomide |
Primary outcome
OS
Time frame: Patients were assessed up to 36 months from enrollment to first death (whichever occurred first)
Defined as the time from the date of randomization to death from any cause.
2 secondary outcomes
PFS
Time frame: From enrollment to the first appearance of disease progression or date death from any cause,whichever came first,assessed up to 36 mounths
ORR
Time frame: From enrollment to initial efficacy evaluation ,assessed up to 6 months
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 2 Jul 2025.
- 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 Fluzoparib with Temozolomide in people with Glioblastoma, run by Tongji Hospital.
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 16 inclusion and 6 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 2 Jul 2025. 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?
OS (time frame: Patients were assessed up to 36 months from enrollment to first death (whichever occurred first)). 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 2 Jul 2025.