Enhanced treatment for newly diagnosed glioblastoma after surgery
Official title: Enhanced Adjuvant Therapy for Newly Diagnosed Glioblastoma With Partial Surgical Resection or Short-term Progression: a Bayesian Adaptive Randomized Phase II Study
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06936046 · Data updated 2026-11-12
This study is testing a new treatment plan for people with newly diagnosed glioblastoma after surgery to see if a combination of different drugs and higher radiation doses works better than the usual care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Hangzhou) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | April 20, 2025 |
| Trial ID | NCT06936046 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a pathologically diagnosed glioblastoma who have undergone partial surgical resection or have experienced short-term progression.
✕Probably not a fit
Patients with severe organ dysfunction or those who do not meet the eligibility criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates an enhanced adjuvant therapy for patients with newly diagnosed glioblastoma who have undergone partial surgical resection or experienced short-term progression. Participants will be randomly assigned to either the standard Stupp regimen or an experimental group receiving a combination of different drugs and increased radiation doses. The study aims to enroll 210 patients, with screening and evaluation conducted prior to randomization. Informed consent will be obtained from all participants before the screening process begins.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with glioblastoma.
How similar studies have gone: Other studies have shown promise with enhanced adjuvant therapies for glioblastoma, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Age: ≥ 18 years old, both male and female are acceptable. 3. Pathologically diagnosed GBM patients 4. Partial surgical resection or recurrence and progression 2-6 weeks after surgery (before radiotherapy) 5. Adequate organ and bone marrow function, without severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction, or immune deficiency: 1. 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). 2. 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). 3. Renal function: Serum creatinine ≤ 1.5 times the upper limit of normal value. 4. 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). 6. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 7. 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. 8. Thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) are all within the normal range of ± 10%. 9. Ophthalmic examination: including dilated pupil fundus examination, slit lamp examination, and fundus color photography. Exclusion Criteria: * 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.
Where it's running
-
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China Recruiting
Study contacts
- Study coordinator: Ting Zhang
- Email: zezht@zju.edu.cn
- Phone: 8615157125533
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
YN003 injection in glioma patients
This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.
-
Brain connectome project in adults with brain glioma undergoing surgery
This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.
-
Lixumistat window of opportunity in newly diagnosed glioblastoma
This study tests whether Lixumistat can benefit adults with newly diagnosed glioblastoma who are planned for surgical tumor removal.
-
Glioblastoma in Réunion: an epidemiological and socio-anthropological look at patients and care
A large group of adults with diffuse gliomas in Réunion is being studied to understand how biology, culture, and health care pathways affect diagnosis and treatment.
-
Butterfly glioblastoma: test adding 5-ALA PoMA with LIDU ultrasound to standard care
This early-phase study tests whether adding 5-ALA–mediated activation with LIDU ultrasound is safe and tolerable for adults with newly diagnosed butterfly glioblastoma, before or during standard chemotherapy and radiotherapy.
-
Maintenance radiotherapy after standard glioblastoma treatment
This study tests whether a single 2 Gy maintenance radiotherapy dose after standard treatment is safe and feasible for adults with newly diagnosed glioblastoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.