GlioblastomaPhase 2NCT07670026
Intensified Adjuvant Therapy for High-Risk Newly Diagnosed Glioblastoma With Subtotal Resection or Short-Term Progression
A Phase 2 study testing Sintilimab, Bevacizumab and Postoperative Radiotherapy in people with Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Brief Summary The goal of this clinical trial is to learn whether intensified adjuvant treatment is safe and may help delay disease progression in adults with high-risk newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Sintilimab, Bevacizumab and Postoperative Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 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 the clinical study: fully understands and is informed about the study and has signed the informed consent form in writing; willing to comply with and able to complete all trial procedures.
- Age: >=18 years; male or female.
- Pathologically confirmed Glioblastoma.
- Subtotal resection or recurrent/progressive disease 4-6 weeks after surgery (before radiotherapy).
- Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency:
- Complete blood count: absolute neutrophil count (ANC) >=1.5*10^9/L (1500/mm3), platelets >=75*10^9/L, hemoglobin >=9 g/dL (if there is bone marrow involvement, platelets >=50*10^9/L, ANC >=1.0*10^9/L, hemoglobin >=8 g/dL).
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- Liver function: serum bilirubin <=1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=1.5 times ULN (if there is liver involvement, AST and ALT <=5 times ULN are allowed).
- Renal function: serum creatinine <=1.5 times ULN.
- Coagulation function: INR <=1.5 times ULN; PT and APTT <=1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT at screening are within the expected range for anticoagulant therapy).
- Left ventricular ejection fraction (LVEF) >=50% on cardiac function examination.
- Negative serum pregnancy test, and effective contraceptive measures from signing the informed consent form until 6 months after the last chemotherapy.
- Thyroid-stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) within the normal range ±10%.
- Ophthalmologic examination: including dilated fundus examination, slit-lamp examination, and color fundus photography.
Who cannot join
- Currently participating in another clinical study, or less than 4 weeks since completion of treatment in a previous clinical study.
- History of malignancy other than Glioblastoma within the past 3 years, or another uncured primary malignancy.
- Prior history of brain radiotherapy.
- Pregnant or lactating women.
- Patients assessed as having contraindications to radiotherapy.
- Severe active comorbidity that would affect the study treatment.
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- Active infection requiring systemic anti-infective treatment, including but not limited to bacterial, fungal, or viral infection.
- Within 6 months before screening, New York Heart Association (NYHA) class III or IV heart failure, unstable angina, severe poorly controlled ventricular arrhythmia, or electrocardiographic evidence of acute ischemia or myocardial infarction.
- QTcF interval >480 msec, unless secondary to bundle branch block.
- Uncontrolled concomitant disease, including but not limited to uncontrolled hypertension, active peptic ulcer disease, or hemorrhagic disease.
- Prior history of mental illness; lack of capacity for civil conduct or limited capacity for civil conduct.
- Any medical history or disease evidence, treatment, or abnormal laboratory value that may interfere with trial results or prevent the subject from fully participating in the study, or any other condition that the investigator considers unsuitable for enrollment.
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
The Second Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang, 310000
Ting Zhang, 86+15157125533, zezht@zju.edu.cn
About this study
Official title: Intensified Adjuvant Therapy for High-Risk Newly Diagnosed Glioblastoma With Subtotal Resection or Short-Term Progression: A Prospective, Single-Arm Phase II Clinical Study
Brief Summary
The goal of this clinical trial is to learn whether intensified adjuvant treatment is safe and may help delay disease progression in adults with high-risk newly diagnosed glioblastoma. High-risk newly diagnosed glioblastoma in this study includes glioblastoma that has been partially removed by surgery or glioblastoma that shows early progression or recurrence before postoperative radiotherapy.
Read more
The main questions this study aims to answer are:
- Does intensified adjuvant treatment improve median progression-free survival in participants with high-risk newly diagnosed glioblastoma?
- How long do participants survive after receiving this treatment?
- What medical problems do participants have during or after intensified adjuvant treatment?
- How often do participants develop radiation necrosis?
- How does this treatment affect participants' quality of life?
Participants will:
- Receive postoperative concurrent radiotherapy and temozolomide chemotherapy.
- Receive a higher radiation dose to the residual tumor or early recurrent/progressive lesion, while standard radiation doses are given to the tumor bed and surrounding high-risk and low-risk areas.
- Receive adjuvant temozolomide after concurrent chemoradiotherapy.
- Receive sintilimab and bevacizumab by intravenous infusion once every 21 days for up to 1 year.
- Have regular blood tests, biochemical tests, thyroid function tests, myocardial enzyme tests, electrocardiograms, and other safety assessments.
- Have enhanced brain MRI scans regularly to evaluate disease status.
- Be followed by clinic visits and/or telephone calls to collect information about disease progression, survival, side effects, later cancer treatments, and quality of life.
- Conditions
- Glioblastoma
- Being tested
- Sintilimab, Bevacizumab, Postoperative Radiotherapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200 mg will be administered by intravenous infusion once every 21 days for up to 1 year as part of enhanced adjuvant therapy after completion of concurrent chemoradiotherapy.
BevacizumabDrug
Bevacizumab 10 mg/kg will be administered by intravenous infusion once every 21 days for up to 1 year as part of enhanced adjuvant therapy after completion of concurrent chemoradiotherapy.
Postoperative RadiotherapyRadiation
Postoperative radiotherapy will be administered as part of concurrent chemoradiotherapy according to the study treatment protocol.
TemozolomideDrug
Temozolomide will be administered concurrently with postoperative radiotherapy for approximately 28 days, followed by adjuvant temozolomide in combination with sintilimab and bevacizumab according to the study treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab plus Bevacizumab | Experimental | For high-risk newly diagnosed glioblastoma patients who undergo partial surgical resection or have short-term recurrent progression 4-6 weeks before radiotherapy after surgery, eligible participants who sign the informed consent form and meet all inclusion and exclusion criteria will receive postoperative concurrent chemoradiotherapy followed by enhanced adjuvant therapy. Concurrent radiotherapy and temozolomide will be administered for approximately 28 days. After completion of concurrent chemoradiotherapy, participants will receive adjuvant temozolomide combined with sintilimab and bevacizumab. Sintilimab 200 mg and bevacizumab 10 mg/kg will be administered by intravenous infusion once every 21 days for up to 1 year. Receives: Drug: Sintilimab; Drug: Bevacizumab; Radiation: Postoperative Radiotherapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival（PFS）
The time from the start of treatment until tumor progression or death from any cause.
Measured: 2 year
Secondary outcomes (3)
Overall Survival (OS)
Measured: 2 year
Quality of life accessed by EORTC-QLQ-C30
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) will be used to assess health-related quality of life. All EORTC QLQ-C30 scores are linearly transformed to a scale ranging from 0 to 100. For the global health status/quality of life scale and functional scales, higher scores indicate better quality of life or better functioning. For symptom scales and single symptom items, higher scores indicate worse symptoms or greater symptom burden.
Measured: 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary safety analysis will be conducted based on subjects who experience toxicity (as defined by CTCAE standards). CTCAE version 5.0 will be used to evaluate safety through reported adverse events.
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 posted25 Jun 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670026
- Sponsor's protocol ID
- Y2025-1805
- Status last verified
- Dec 2025
- First submitted
- 15 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified Adjuvant Therapy for High-Risk Newly Diagnosed Glioblastoma With Subtotal Resection or Short-Term Progression: A Prospective, Single-Arm Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07670026
- Acronym / sponsor ID
- Y2025-1805
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Jun 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.
Brief Summary
The goal of this clinical trial is to learn whether intensified adjuvant treatment is safe and may help delay disease progression in adults with high-risk newly diagnosed glioblastoma. High-risk newly diagnosed glioblastoma in this study includes glioblastoma that has been partially removed by surgery or glioblastoma that shows early progression or recurrence before postoperative radiotherapy.
The main questions this study aims to answer are:
- Does intensified adjuvant treatment improve median progression-free survival in participants with high-risk newly diagnosed glioblastoma?
- How long do participants survive after receiving this treatment?
- What medical problems do participants have during or after intensified adjuvant treatment?
- How often do participants develop radiation necrosis?
- How does this treatment affect participants' quality of life?
Participants will:
- Receive postoperative concurrent radiotherapy and temozolomide chemotherapy.
- Receive a higher radiation dose to the residual tumor or early recurrent/progressive lesion, while standard radiation doses are given to the tumor bed and surrounding high-risk and low-risk areas.
- Receive adjuvant temozolomide after concurrent chemoradiotherapy.
- Receive sintilimab and bevacizumab by intravenous infusion once every 21 days for up to 1 year.
- Have regular blood tests, biochemical tests, thyroid function tests, myocardial enzyme tests, electrocardiograms, and other safety assessments.
- Have enhanced brain MRI scans regularly to evaluate disease status.
- Be followed by clinic visits and/or telephone calls to collect information about disease progression, survival, side effects, later cancer treatments, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab plus Bevacizumab | Experimental | Drug: Sintilimab, Drug: Bevacizumab, Radiation: Postoperative Radiotherapy, Drug: TemozolomideFor high-risk newly diagnosed glioblastoma patients who undergo partial surgical resection or have short-term recurrent progression 4-6 weeks before radiotherapy after surgery, eligible participants who sign the informed consent form and meet all inclusion and exclusion criteria will receive postoperative concurrent chemoradiotherapy followed by enhanced adjuvant therapy. Concurrent radiotherapy and temozolomide will be administered for approximately 28 days. After completion of concurrent chemoradiotherapy, participants will receive adjuvant temozolomide combined with sintilimab and bevacizumab. Sintilimab 200 mg and bevacizumab 10 mg/kg will be administered by intravenous infusion once every 21 days for up to 1 year. |
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 the clinical study: fully understands and is informed about the study and has signed the informed consent form in writing; willing to comply with and able to complete all trial procedures.
- Age: >=18 years; male or female.
- Pathologically confirmed Glioblastoma.
- Subtotal resection or recurrent/progressive disease 4-6 weeks after surgery (before radiotherapy).
- Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency:
Key exclusion criteria (12 listed)
- Currently participating in another clinical study, or less than 4 weeks since completion of treatment in a previous clinical study.
- History of malignancy other than Glioblastoma within the past 3 years, or another uncured primary malignancy.
- Prior history of brain radiotherapy.
- Pregnant or lactating women.
- Patients assessed as having contraindications to radiotherapy.
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 |
|---|---|---|
| SintilimabSintilimab 200 mg will be administered by intravenous infusion once every 21 days for up to 1 year as part of enhanced adjuvant therapy after completion of concurrent chemoradiotherapy. | Drug | Sintilimab plus Bevacizumab |
| BevacizumabBevacizumab 10 mg/kg will be administered by intravenous infusion once every 21 days for up to 1 year as part of enhanced adjuvant therapy after completion of concurrent chemoradiotherapy. | Drug | Sintilimab plus Bevacizumab |
| Postoperative RadiotherapyPostoperative radiotherapy will be administered as part of concurrent chemoradiotherapy according to the study treatment protocol. | Radiation | Sintilimab plus Bevacizumab |
| TemozolomideTemozolomide will be administered concurrently with postoperative radiotherapy for approximately 28 days, followed by adjuvant temozolomide in combination with sintilimab and bevacizumab according to the study treatment protocol. | Drug | Sintilimab plus Bevacizumab |
Primary outcome
Progression Free Survival（PFS）
Time frame: 2 year
The time from the start of treatment until tumor progression or death from any cause.
3 secondary outcomes
Overall Survival (OS)
Time frame: 2 year
Quality of life accessed by EORTC-QLQ-C30
Time frame: 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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 25 Jun 2026.
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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 Sintilimab, Bevacizumab and Postoperative Radiotherapy 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 12 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 25 Jun 2026. 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, Dr. (86+15157125533, zezht@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival（PFS） (time frame: 2 year). 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 25 Jun 2026.