Glioblastoma
Conditions
Interventions
Intervention Group:Multimodal MRI–guided carbon ion–induced radiotherapy combined with the Stupp regimen plus concurrent/adjuvant anlotinib
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects who are willing to receive carbon ion radiotherapy, voluntarily participate in this study, have provided written informed consent, and demonstrate good compliance; 2. Age =18 years at the time of signing informed consent; Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; and an estimated life expectancy of more than 3 months; 3. Histologically confirmed newly diagnosed or recurrent glioblastoma, according to the WHO Classification of Tumors of the Central Nervous System (2021); 4. Within 7 weeks after surgery, with adequate postoperative wound healing; 5. Stable or tapering dose of corticosteroids within 5 days prior to randomization; 6. Adequate major organ function, meeting the following criteria: a) Hematologic function (no blood transfusion or use of hematopoietic growth factors within 7 days prior to screening): • Hemoglobin (HGB) >= 90 g/L; • Absolute neutrophil count (ANC) >= 1.5 × 10?/L; • Platelet count (PLT) >= 90 × 10?/L. b) Biochemical function: • Total bilirubin (TBIL) = 60 mL/min; c) Coagulation, thyroid, and cardiac function: • Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) = 50% as assessed by echocardiography. 7. Female subjects of childbearing potential must agree to use effective contraception (e.g., intrauterine device or condom) during the study and for 6 months after study completion; must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Concomitant diseases and medical history: a) History of, or current, other malignancies within the past 3 years. The following exceptions are allowed: • Other malignancies treated with curative surgery alone with a disease-free survival (DFS) of >=5 years; • Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors [Ta (non–muscle-invasive), Tis (carcinoma in situ), and T1 (tumor invasion of the basement membrane)]; b) Conditions that may interfere with oral drug administration, such as inability to swallow, chronic diarrhea, or intestinal obstruction; c) Adverse events related to prior therapies that have not recovered to =150 mmHg or diastolic blood pressure >=100 mmHg); • >= Grade 2 myocardial ischemia or myocardial infarction, cardiac arrhythmias (including QTc >=450 ms for males or >=470 ms for females), or >= Grade 2 congestive heart failure according to the New York Heart Association (NYHA) classification; • Active or uncontrolled severe infection (>= Grade 2 infection per CTCAE v5.0); • Current pneumonia of CTCAE v5.0 Grade >=2; • Liver cirrhosis or active hepatitis*; 2. Definition of active hepatitis: for hepatitis B, HBsAg positivity with HBV DNA >1 × 10³ copies/mL or >2000 IU/mL; for hepatitis C, positive anti-HCV antibody with HCV RNA levels above the upper limit of normal. • Renal failure requiring hemodialysis or peritoneal dialysis; • History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency disorders, or prior organ transplantation; • Poorly controlled diabetes mellitus (fasting blood glucose >10 mmol/L); • Urinalysis showing proteinuria >=++ with confirmed 24-hour urinary protein excretion >1.0 g. 3. Tumor-related symptoms and prior treatments: • Prior cranial radiotherapy with irradiated fields overlapping or adjacent to the planned study radiotherapy fields; • Contraindications to or inability to undergo MRI examination; • Imaging (CT/MRI) evidence of tumor invasion of major blood vessels, or tumors deemed by the investigator to have a high likelihood of invading major vessels during the study period, with a risk of fatal massive hemorrhage or other bleeding tendencies; • Diffuse leptomeningeal dissemination; • Definite history of neurological or psychiatric disorders, moderate or severe epilepsy (excluding mild epilepsy secondary to WHO grade IV glioblastoma), or moderate or severe aphasia or dementia. Participation in another clinical trial involving anti-tumor agents within 4 weeks prior to randomization; 4. Any concomitant disease or condition that, in the investigator’s judgment, may seriously compromise subject safety, interfere with study completion, or render the subject unsuitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AE) and serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactFeng Jiang
Zhejiang Cancer Hospital
Outcome results
None listed