Actively Recruiting
Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-04-20
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older, male or female
- Pathological diagnosis of glioblastoma (GBM)
- Partial surgical resection or recurrence/progression 2-6 weeks after surgery and before radiotherapy
- Adequate organ and bone marrow function without severe hematopoietic, heart, lung, liver, kidney dysfunction, or immune deficiency
- Blood routine: ANC 1.5 x 10^9/L (1500/mm3), platelets 75 x 10^9/L, hemoglobin 9 g/dL (if bone marrow involved: platelets 50 x 10^9/L, ANC 1.0 x 10^9/L, hemoglobin 8 g/dL)
- Liver function: serum bilirubin 1.5 times upper limit normal, AST and ALT 1.5 times upper limit normal (ALT 5 times if liver involved)
- Renal function: serum creatinine 1.5 times upper limit normal
- Coagulation: INR, PT, and APTT 1.5 times upper limit normal (if on anticoagulants, within expected range)
- Cardiac function: left ventricular ejection fraction 50%
- Negative pregnancy test and use of effective contraception from consent until 6 months after last chemotherapy
- Thyroid hormones (TSH, FT4, FT3) within normal range �B1 10%
- Ophthalmic exam including dilated pupil fundus, slit lamp, and fundus photography
You will not qualify if you...
- Currently in other clinical studies or less than 4 weeks since previous clinical study treatment ended
- History of other malignant tumors within past 3 years or uncured primary malignancies other than GBM
- Previous brain radiation therapy
- Pregnant or breastfeeding women
- Contraindications to radiotherapy
- Serious active comorbidities affecting treatment
- Active infections requiring systemic anti-infective treatment
- Heart failure, unstable angina, severe uncontrolled arrhythmias, acute ischemia, or myocardial infarction within 6 months
- QTcF interval longer than 480 milliseconds unless due to bundle branch block
- Uncontrolled comorbidities such as hypertension, active peptic ulcers, or bleeding disorders
- History of mental illness or lack of legal capacity
- Medical conditions or abnormalities that may interfere with study results or full participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
Actively Recruiting
Research Team
T
Ting Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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