Phase
Condition
Astrocytoma
Gliomas
Treatment
Stupp protocol
Dual antibody A
Modified Stupp
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation in clinical research: fully understand and be informed ofthis study, and sign a written informed consent form; Willing to follow and capableComplete 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).
Liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 timesthe upper limit of normal value (AST is allowed if there is liver involvement,ALT ≤ 5 times the upper limit of normal value).
Renal function: Serum creatinine ≤ 1.5 times the upper limit of normal value.
Coagulation function: INR ≤ 1.5 times the upper limit of normal value; PT andAPTT are ≤ 1.5 times the upper limit of normal values (unless the subject isreceiving anticoagulant treatment and PT and APTT are within the expected rangeof anticoagulant treatment at the time of screening).
Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
The serum pregnancy test is negative, and effective contraceptive measures have beentaken from the signing of the informed consent form until 6 months after the lastchemotherapy.
Thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) are all within the normal range of ± 10%.
Ophthalmic examination: including dilated pupil fundus examination, slit lampexamination, and fundus color photography.
Exclusion
Exclusion Criteria:
Currently participating in other clinical studies, or less than 4 weeks afterthe end of treatment in the previous clinical study.
In the past 3 years, there has been a history of malignant tumors other thanGBM, 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, includingbut not limited to bacterial, fungal, or viral infections.
Patients with heart failure, unstable angina, severe uncontrolled ventriculararrhythmias, acute ischemia or myocardial infarction as determined by the NewYork Heart Association (NYHA) functional classification within the first 6months of screening.
QTcF interval>480milliseconds, unless secondary to bundle branch block. 10)Suffering from uncontrollable comorbidities, including but not limited touncontrolled hypertension, active peptic ulcers, or bleeding disorders.
Individuals with a history of mental illness in the past; Individuals withoutlegal 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 orlaboratory test values, or other situations that the researchers consider unsuitablefor inclusion.
Study Design
Connect with a study center
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou,
ChinaActive - Recruiting
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