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Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression

RecruitingPhase 2Ages 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, …
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In plain words

What the trial is, and whether it could suit you

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 en

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Dual antibody A
  • Dual antibody B
  • Modified Stupp
  • Stupp protocol
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Where

1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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