TrialBridgeNCT06936046
Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression
Recruiting · Phase 2 · Second Affiliated Hospital, Zhejiang University, School of Medicine · registry updated 2025-04-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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.
- Age: ≥ 18 years old, both male and female are acceptable.
- Pathologically diagnosed GBM patients
- Partial surgical resection or recurrence and progression 2-6 weeks after surgery (before radiotherapy)
- Adequate organ and bone marrow function, without severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction, or immune deficiency:
- 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).
Exclusion
- \) Currently participating in other clinical studies, or less than 4 weeks after the end of treatment in the previous clinical study.
- \) 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.
- \) 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.
- \) 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.
- \) 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.
- \) Individuals with a history of mental illness in the past; Individuals without legal capacity or with limited legal capacity.