Glioblastoma
Conditions
Interventions
Experimental group:Concurrent radiotherapy plus adjuvant temozolomide chemotherapy combined with sertraline
Control group:Concurrent radiotherapy and adjuvant temozolomide chemotherapy
Sponsors
Tangdu Hospital of the Fourth Military Medical University of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The subject voluntarily participates in this study, signs the informed consent form, and demonstrates good compliance. Age: 18–75 years at the time of informed consent signing; Karnofsky Performance Status (KPS) score = 60; expected survival duration longer than 3 months. Histologically confirmed diagnosis of glioblastoma multiforme. At least 28 days shall have elapsed between the last surgery (including biopsy, surgical resection, or other intracranial procedures) and randomization, with satisfactory surgical wound healing assessed by the investigator. Within 7 days prior to dosing, the dose of corticosteroids shall be stable or gradually tapered, and the maximum corticosteroid dose shall not exceed the dexamethasone equivalent of 4 mg. Adequate function of major organs, meeting the following criteria: a. Hematological parameters (no blood transfusion or hematopoietic stimulating factors administered within 7 days before randomization): hemoglobin (HGB) = 90 g/L; absolute neutrophil count (NEUT) = 1.5×10?/L; platelet count (PLT) = 90×10?/L. b. Biochemical criteria: total bilirubin (TBIL) = 1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) = 2.5 × ULN; serum creatinine (Cr) = 1.5 × ULN or creatinine clearance (Ccr) = 60 mL/min. c. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) = 1.5 × ULN (for subjects without anticoagulant treatment). d. Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%. Women of childbearing potential must agree to use effective contraceptive measures (e.g., intrauterine device, contraceptives, condoms) throughout the study and for 6 months after study completion, have a negative serum pregnancy test within 7 days prior to enrollment, and be non-lactating. Male subjects must agree to maintain effective contraception during the study and for 6 months following the end of study treatment.
Exclusion criteria
Exclusion criteria: Previous receipt of systemic radiotherapy and chemotherapy for glioblastoma multiforme; Presence of IDH1/2 mutations; Subjects unable to undergo MRI examination; Tumor limited solely to the brainstem; Radiographically evident diffuse leptomeningeal dissemination; Tumors invading major blood vessels on MRI imaging; or those judged by the investigator to be at extremely high risk of life-threatening massive hemorrhage due to vascular invasion during the study period; or with cerebrovascular malformations or other bleeding diathesis; Arterial thrombosis, venous thrombosis or tumor thrombus events within 6 months prior to enrollment, including cerebrovascular accidents (transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc.; History of other malignant tumors within 5 years before enrollment or concurrent active malignancy at present; Presence of any conditions affecting oral drug absorption, such as dysphagia, chronic diarrhea, intestinal obstruction, etc.; Subjects with any severe and/or uncontrolled underlying diseases, including: a) Poorly controlled hypertension (systolic blood pressure = 150 mmHg or diastolic blood pressure = 100 mmHg); b) Grade = 2 myocardial ischemia, myocardial infarction, arrhythmia (including QTc = 500 ms in males and QTc = 470 ms in females), or Grade = 2 congestive heart failure (NYHA functional classification); c) Active or uncontrolled severe infection (CTCAE Grade = 2); d) Current pneumonia with CTCAE Grade = 2; e) History of clinically significant liver diseases. Including viral hepatitis; known HBV carriers must be excluded if with active HBV infection defined as positive HBV-DNA (>2500 copies/mL or >500 IU/mL and above the upper limit of normal); confirmed HCV infection with positive HCV-RNA (>1×10³ copies/mL), or other decompensated liver diseases; f) History of immunodeficiency diseases, including HIV positivity, other acquired or congenital immunodeficiency disorders, or a history of solid organ transplantation; g) Poorly controlled diabetes (fasting blood glucose > 10 mmol/L); h) Clinically significant thyroid dysfunction that cannot be normalized with medical treatment or remains clinically unstable. Previous treatment with proprietary Chinese medicines with approved antitumor indications stated in the NMPA labeling, including Compound Mylabris Capsules, Kang’ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea Javanica Oil Injection/Capsules, Xiao’aiping Tablets/Injection, Cinobufacin Capsules, or other traditional Chinese medicinal preparations with antitumor components; Well-documented history of neurological or psychiatric diseases, drug-refractory epilepsy (excluding mild epilepsy secondary to glioblastoma multiforme), moderate or higher aphasia, or dementia; Participation in other interventional antitumor clinical trials within 4 weeks prior to enrollment; Subjects with concomitant diseases that may seriously compromise safety or interfere with study completion, or any other conditions deemed inappropriate for enrollment by the investigator’s judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;PFS rate at 6 months;12-month OS rate;Quality of life;Cognitive function;Usage of corticosteroid hormones;Incidence and severity of adverse events (AE) and serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival period;Abnormal laboratory test indicators; | — |
Countries
China
Contacts
Public ContactLiang Wang
Tangdu Hospital of the Fourth Military Medical University of the People's Liberation Army of China
Outcome results
None listed