Aggressive combo therapy takes on tough brain cancer
NCT ID NCT07670026
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial tests whether an intensified treatment plan can delay tumor growth in adults with high-risk glioblastoma that was only partially removed or came back quickly. Participants receive higher radiation doses to the remaining tumor, plus chemotherapy and two immunotherapy drugs (sintilimab and bevacizumab) for up to a year. The study will track how long people live without their cancer worsening, overall survival, side effects, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sintilimab, bevacizumab, temozolomide, and higher-dose radiation
- What this could lead to
- If it works, this could point toward a more effective treatment strategy for high-risk glioblastoma that is hard to treat with standard therapy.
- What could go wrong
- This is a small, early-phase (phase II) study with only 31 participants, so results may not apply to all patients. The intensified regimen also carries higher risks of side effects like radiation necrosis.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * 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: 1. 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). 2. 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). 3. Renal function: serum creatinine \<=1.5 times ULN. 4. 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. Exclusion Criteria: * 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glioblastoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
Contacts and locations
Locations
-
The Second Affiliated Hospital,School of Medicine,Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a trio of repurposed drugs shrink recurrent brain tumors?
- Can an existing drug boost bevacizumab against recurrent brain cancer?
- One extra radiation dose after standard brain cancer therapy: can it boost the immune system?
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Can a common virus vaccine help fight brain cancer?
- Radioactive tiles target brain tumors in frail patients