GlioblastomaPhase 2NCT06936046
Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression
A Phase 2 study testing Dual antibody A, Dual antibody B and Modified Stupp in people with Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is a prospective Bayesian adaptive randomized phase II clinical trial of enhanced adjuvant therapy for newly diagnosed glioblastoma with partial surgical resection or short-term progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Dual antibody A, Dual antibody B and Modified Stupp
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in clinical research: fully understand and be informed of this study, and sign a written informed consent form; Willing to follow and capable Complete all experimental procedures.
- Age: ≥ 18 years old, both male and female are acceptable.
- Pathologically diagnosed GBM patients
- Partial surgical resection or recurrence and progression 2-6 weeks after surgery (before radiotherapy)
- Adequate organ and bone marrow function, without severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction, or immune deficiency:
- Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 * 109/L (1500/mm3), platelets ≥ 75 * 109/L, hemoglobin ≥ 9 g/dL (if bone marrow is involved, platelets ≥ 50 * 109/L, ANC ≥ 1.0 * 109/L, hemoglobin ≥ 8 g/dL).
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- Liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal value (AST is allowed if there is liver involvement, ALT ≤ 5 times the upper limit of normal value).
- Renal function: Serum creatinine ≤ 1.5 times the upper limit of normal value.
- Coagulation function: INR ≤ 1.5 times the upper limit of normal value; PT and APTT are ≤ 1.5 times the upper limit of normal values (unless the subject is receiving anticoagulant treatment and PT and APTT are within the expected range of anticoagulant treatment at the time of screening).
- Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
- The serum pregnancy test is negative, and effective contraceptive measures have been taken from the signing of the informed consent form until 6 months after the last chemotherapy.
- Thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) are all within the normal range of ± 10%.
- Ophthalmic examination: including dilated pupil fundus examination, slit lamp examination, and fundus color photography.
Who cannot join
- 1) Currently participating in other clinical studies, or less than 4 weeks after the end of treatment in the previous clinical study.
- 2) In the past 3 years, there has been a history of malignant tumors other than GBM, or other primary malignant tumors that have not been cured.
- 3) Previous history of brain radiation therapy. 4) Pregnant or lactating women. 5) After evaluation, there are patients with contraindications to radiotherapy. 6) Serious active comorbidities that may affect the treatment of this study. 7) Active infections that require systematic anti infective treatment, including but not limited to bacterial, fungal, or viral infections.
- 8) Patients with heart failure, unstable angina, severe uncontrolled ventricular arrhythmias, acute ischemia or myocardial infarction as determined by the New York Heart Association (NYHA) functional classification within the first 6 months of screening.
- 9) QTcF interval>480milliseconds, unless secondary to bundle branch block. 10) Suffering from uncontrollable comorbidities, including but not limited to uncontrolled hypertension, active peptic ulcers, or bleeding disorders.
- 11) Individuals with a history of mental illness in the past; Individuals without legal capacity or with limited legal capacity.
- 12)Medical history or disease evidence that may interfere with the trial results, hinder the subjects' full participation in the study, abnormal treatment or laboratory test values, or other situations that the researchers consider unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou
Ting Zhang, 8615157125533, zezht@zju.edu.cn
About this study
Official title: Enhanced Adjuvant Therapy for Newly Diagnosed Glioblastoma With Partial Surgical Resection or Short-term Progression: a Bayesian Adaptive Randomized Phase II Study
This study is a prospective Bayesian adaptive randomized phase II clinical trial of enhanced adjuvant therapy for newly diagnosed glioblastoma with partial surgical resection or short-term progression. The Stupp regimen is the standard treatment regimen (control group), while the experimental group receives enhanced treatment by combining different drugs or increasing the radiation dose based on the Stupp standard treatment regimen. Participants will undergo screening and evaluation according to the inclusion and exclusion criteria of the protocol, within 28 days prior to randomization. Patients who agree to participate in this study will sign an informed consent form (ICF) prior to the screening process. After completing all screening activities, those who meet the criteria can start receiving study treatment. Based on sample size estimation, a total of 210 patients are planned to be enrolled. Among the first 28 patients, an average of 7 patients will be allocated to each group for initial randomization to ensure the balance of each group in the early stages of the trial. Starting from the 29th patient, the 12-month PFS rate will be re estimated for every 15 patients enrolled, and the subsequent randomization probability will be calculated based on the observed data. On the first day of self adjuvant therapy, the PD-1/VEGF bispecific group received intravenous administration of PD-1/VEGF bispecific antibody 20mg/kg treatment, with 21 days per cycle, is expected to be administered for a total of 8 cycles. The PD-1/CTLA-4 dual antibody group received intravenous infusion of 6mg/kg PD-1/CTLA-4 dual antibody once on the first day of self adjuvant therapy, with 14 days per cycle. It is expected to be administered for a total of 12 cycles. The dose adjusted Stupp regimen group (mStupp) administered PGTV locally to residual or short-term recurrent lesions after surgery 66Gy/30Gy high-dose irradiation, PTV1 60Gy/30F in high-risk areas around the tumor bed, and 54Gy/30F radiotherapy in low-risk areas. Each group will have weekly blood routine, liver and kidney function, myocardial enzyme spectrum, thyroid function, electrocardiogram, and head MR every 4 weeks to evaluate the efficacy and toxic side effects. Follow up observation will be conducted. The study will start on January 1, 2025 and end on December 31, 2027, to explore the efficacy of enhanced adjuvant therapy for newly diagnosed glioblastoma with partial surgical resection or short-term progression.
- Conditions
- Glioblastoma
- Being tested
- Dual antibody A, Dual antibody B, Modified Stupp, Stupp protocol
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual antibody ADrug
Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/VEGF dual antibody will be used as adjuvant therapy. PD-1/VEGF dual antibody 20mg/kg intravenous infusion once, with a cycle of 21 days.
Dual antibody BDrug
Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/CTLA-4 dual antibody will be used as adjuvant therapy. PD-1/CTLA-4 dual antibody 6mg/kg intravenous infusion once, with a cycle of 14 days.
Modified StuppRadiation
Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. For partially resected lesions or short-term recurrence and progression lesions after surgery, high-dose PGTV 66Gy/30Gy will be given locally. PTV1 in high-risk areas around the tumor bed will be 60Gy/30F, and in low-risk areas will be 54Gy/30F. After completing synchronous radiotherapy and chemotherapy for 28 days, 6 cycles of adjuvant TMZ chemotherapy will be started.
Stupp protocolDrug
Synchronized TMZ radiotherapy and chemotherapy will begin 2-6 weeks after surgery, and 6 cycles of adjuvant TMZ chemotherapy will begin 28 days after completing the synchronized radiotherapy and chemotherapy. Radiotherapy regimen: PTV1 60Gy/30F in high-risk areas around the tumor bed, 54Gy/30F in low-risk areas. TMZ synchronous chemotherapy regimen: 75mg/m2 po qd. TMZ adjuvant chemotherapy regimen: The first cycle is 150mg/m2 po qd on d1-5,28 days; Cycle 2-6: Cycle 1: 200mg/m2 po qd for d1-5,28 days.
| Study group | Role | What they receive |
|---|---|---|
| Stupp group | Active comparator | radiotherapy+TMZ synchronous chemotherapy+TMZ adjuvant chemotherapy Receives: Drug: Stupp protocol |
| Dual antibody group A | Experimental | radiotherapy+TMZ synchronous chemotherapy+TMZ combined with PD-1/VEGF dual antibody adjuvant therapy Receives: Drug: Dual antibody A |
| Dual antibody group B | Experimental | radiotherapy+TMZ synchronous chemotherapy+TMZ combined with PD-1/CTLA-4 dual antibody adjuvant therapy Receives: Drug: Dual antibody B |
| Modified Stupp group | Experimental | radiotherapy+TMZ synchronous chemotherapy+TMZ adjuvant chemotherapy Receives: Radiation: Modified Stupp |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 months PFS rate
The proportion of patients in the population who did not progress and survived after 3 months of treatment after enrollment (using RANO 2.0 criteria).
Measured: 3 months
6 months PFS rate
The proportion of patients in the population who did not progress and survived after 6 months of treatment after enrollment(using RANO 2.0 criteria).
Measured: 6 months
1-year PFS rate
The proportion of patients in the population who did not progress and survived after 12 months of treatment after enrollment (using RANO 2.0 criteria).
Measured: 1-year
Secondary outcomes (3)
OS rate
The survival rate of patients in different time periods after starting treatment after enrollment.
Measured: 3/6/12/24 months
Changes in Quality of Life
Use EORTC QLQ-C30 scale to monitor changes in quality of life at baseline and during treatment.
Measured: 2 years
The incidence and severity of radiation-induced brain necrosis
Monitoring the incidence and severity of radiation-induced brain necrosis based on CTCAE version 5.0 standard.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936046
- Sponsor's protocol ID
- Y2024-1311
- Status last verified
- Jan 2025
- First submitted
- 3 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Adjuvant Therapy for Newly Diagnosed Glioblastoma With Partial Surgical Resection or Short-term Progression: a Bayesian Adaptive Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT06936046
- Acronym / sponsor ID
- Y2024-1311
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Apr 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.
This study is a prospective Bayesian adaptive randomized phase II clinical trial of enhanced adjuvant therapy for newly diagnosed glioblastoma with partial surgical resection or short-term progression. The Stupp regimen is the standard treatment regimen (control group), while the experimental group receives enhanced treatment by combining different drugs or increasing the radiation dose based on the Stupp standard treatment regimen. Participants will undergo screening and evaluation according to the inclusion and exclusion criteria of the protocol, within 28 days prior to randomization. Patients who agree to participate in this study will sign an informed consent form (ICF) prior to the screening process. After completing all screening activities, those who meet the criteria can start receiving study treatment. Based on sample size estimation, a total of 210 patients are planned to be enrolled. Among the first 28 patients, an average of 7 patients will be allocated to each group for initial randomization to ensure the balance of each group in the early stages of the trial. Starting from the 29th patient, the 12-month PFS rate will be re estimated for every 15 patients enrolled, and the subsequent randomization probability will be calculated based on the observed data. On the first day of self adjuvant therapy, the PD-1/VEGF bispecific group received intravenous administration of PD-1/VEGF bispecific antibody 20mg/kg treatment, with 21 days per cycle, is expected to be administered for a total of 8 cycles. The PD-1/CTLA-4 dual antibody group received intravenous infusion of 6mg/kg PD-1/CTLA-4 dual antibody once on the first day of self adjuvant therapy, with 14 days per cycle. It is expected to be administered for a total of 12 cycles. The dose adjusted Stupp regimen group (mStupp) administered PGTV locally to residual or short-term recurrent lesions after surgery 66Gy/30Gy high-dose irradiation, PTV1 60Gy/30F in high-risk areas around the tumor bed, and 54Gy/30F radiotherapy in low-risk areas. Each group will have weekly blood routine, liver and kidney function, myocardial enzyme spectrum, thyroid function, electrocardiogram, and head MR every 4 weeks to evaluate the efficacy and toxic side effects. Follow up observation will be conducted. The study will start on January 1, 2025 and end on December 31, 2027, to explore the efficacy of enhanced adjuvant therapy for newly diagnosed glioblastoma with partial surgical resection or short-term progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stupp group | Active comparator | Drug: Stupp protocolradiotherapy+TMZ synchronous chemotherapy+TMZ adjuvant chemotherapy |
| Dual antibody group A | Experimental | Drug: Dual antibody Aradiotherapy+TMZ synchronous chemotherapy+TMZ combined with PD-1/VEGF dual antibody adjuvant therapy |
| Dual antibody group B | Experimental | Drug: Dual antibody Bradiotherapy+TMZ synchronous chemotherapy+TMZ combined with PD-1/CTLA-4 dual antibody adjuvant therapy |
| Modified Stupp group | Experimental | Radiation: Modified Stuppradiotherapy+TMZ synchronous chemotherapy+TMZ adjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary participation in clinical research: fully understand and be informed of this study, and sign a written informed consent form; Willing to follow and capable Complete all experimental procedures.
- Age: ≥ 18 years old, both male and female are acceptable.
- Pathologically diagnosed GBM patients
- Partial surgical resection or recurrence and progression 2-6 weeks after surgery (before radiotherapy)
- Adequate organ and bone marrow function, without severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction, or immune deficiency:
Key exclusion criteria (7 listed)
- 1) Currently participating in other clinical studies, or less than 4 weeks after the end of treatment in the previous clinical study.
- 2) In the past 3 years, there has been a history of malignant tumors other than GBM, or other primary malignant tumors that have not been cured.
- 3) Previous history of brain radiation therapy. 4) Pregnant or lactating women. 5) After evaluation, there are patients with contraindications to radiotherapy. 6) Serious active comorbidities that may affect the treatment of this study. 7) Active infections that require systematic anti infective treatment, including but not limited to bacterial, fungal, or viral infections.
- 8) Patients with heart failure, unstable angina, severe uncontrolled ventricular arrhythmias, acute ischemia or myocardial infarction as determined by the New York Heart Association (NYHA) functional classification within the first 6 months of screening.
- 9) QTcF interval>480milliseconds, unless secondary to bundle branch block. 10) Suffering from uncontrollable comorbidities, including but not limited to uncontrolled hypertension, active peptic ulcers, or bleeding disorders.
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 |
|---|---|---|
| Dual antibody AStarting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/VEGF dual antibody will be used as adjuvant therapy. PD-1/VEGF dual antibody 20mg/kg intravenous infusion once, with a cycle of 21 days. | Drug | Dual antibody group A |
| Dual antibody BStarting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/CTLA-4 dual antibody will be used as adjuvant therapy. PD-1/CTLA-4 dual antibody 6mg/kg intravenous infusion once, with a cycle of 14 days. | Drug | Dual antibody group B |
| Modified StuppStarting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. For partially resected lesions or short-term recurrence and progression lesions after surgery, high-dose PGTV 66Gy/30Gy will be given locally. PTV1 in high-risk areas around the tumor bed will be 60Gy/30F, and in low-risk areas will be 54Gy/30F. After completing synchronous radiotherapy and chemotherapy for 28 days, 6 cycles of adjuvant TMZ chemotherapy will be started. | Radiation | Modified Stupp group |
| Stupp protocolSynchronized TMZ radiotherapy and chemotherapy will begin 2-6 weeks after surgery, and 6 cycles of adjuvant TMZ chemotherapy will begin 28 days after completing the synchronized radiotherapy and chemotherapy. Radiotherapy regimen: PTV1 60Gy/30F in high-risk areas around the tumor bed, 54Gy/30F in low-risk areas. TMZ synchronous chemotherapy regimen: 75mg/m2 po qd. TMZ adjuvant chemotherapy regimen: The first cycle is 150mg/m2 po qd on d1-5,28 days; Cycle 2-6: Cycle 1: 200mg/m2 po qd for d1-5,28 days. | Drug | Stupp group |
Primary outcome
3 months PFS rate
Time frame: 3 months
The proportion of patients in the population who did not progress and survived after 3 months of treatment after enrollment (using RANO 2.0 criteria).
6 months PFS rate
Time frame: 6 months
The proportion of patients in the population who did not progress and survived after 6 months of treatment after enrollment(using RANO 2.0 criteria).
1-year PFS rate
Time frame: 1-year
The proportion of patients in the population who did not progress and survived after 12 months of treatment after enrollment (using RANO 2.0 criteria).
3 secondary outcomes
OS rate
Time frame: 3/6/12/24 months
Changes in Quality of Life
Time frame: 2 years
The incidence and severity of radiation-induced brain necrosis
Time frame: 2 years
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 20 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dual antibody A, Dual antibody B and Modified Stupp in people with Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 13 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ting Zhang (8615157125533, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 months PFS rate (time frame: 3 months). The study lists 3 primary outcomes in all. 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 20 Apr 2025.