Metastasis to the meninges from solid tumors
Conditions
Interventions
Interventions group:intrathecal thiotepa combined with bevacizumab
Sponsors
Qingdao Centeral Hospital ,University of Health and Rehabilitation Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed solid tumors; 2. Investigator diagnosis based on cerebrospinal fluid cytology (detection of tumor cells in CSF is the gold standard for confirmation),clinical presentation (new neurological symptoms and signs such as headache, nausea, vomiting, seizures, cognitive impairment, etc.) and neuroimaging findings (CT or MRI showing meningeal thickening, nodular or linear enhancement,ventricular system changes, etc.) 3. Ommaya reservoir implantable or already implanted; 4. No extracranial tumor lesions, or extracranial tumor lesions stable for the past 3 months; 5. No brain parenchymal metastases, or stable brain parenchymal metastases within the past 3 months with no anticipated need for brain radiotherapy within the next 3 months; 6. ECOG PS 0-3; 7. Adequate bone marrow and hepatic/renal reserve function: Absolute neutrophil count (ANC) >= 1.5 x 10?/L, platelets >= 100 x 10?/L,hemoglobin >= 90 g/L. International Normalized Ratio (INR) or prothrombin time (PT) = 90 g/L. International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 x ULN. Activated Partial Thromboplastin Time (aPTT) <= 1.5 x ULN. Serum total bilirubin <= 1.5 x ULN (Gilbert syndrome subjects may be enrolled if total bilirubin < 3 x ULN).Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN; if the subject has liver metastases, this criterion is AST and ALT <= 5 x ULN. 8. Age between 18 and 80 years.
Exclusion criteria
Exclusion criteria: 1. Received brain radiotherapy or intrathecal administration of antineoplastic drugs within the past 3 months; 2. History of intrathecal administration of cetipar; 3. Presence of contraindications for Ommaya reservoir implantation or planned Ommaya reservoir placement combined with other surgical procedures; 4. Active bleeding detected on pre-enrollment cranial CT or MRI scan; 5. Uncontrolled hypertension with systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg despite antihypertensive therapy; 6. History within 3 months prior to enrollment of decompensated heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, or persistent clinically significant arrhythmia; 7. Refusal to undergo cerebrospinal fluid ctDNA testing; 8. Estimated survival period <3 months; 9. Presence of severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency, deemed by the investigator as unsuitable for trial participation or potentially affecting subject compliance with the protocol, such as active infection; 10. Extensive interstitial lung disease or respiratory failure; 11. Toxicity from prior treatment not recovered to baseline or NCI-CTCAE 5.0 Grade 1; 12. Known drug allergy or metabolic disorder to any drug in this protocol; 13. Pregnant or lactating women; females planning pregnancy within 6 months after the last study dose; 14. Concurrent participation in other clinical studies; 15. Presence of acute thrombotic events, including but not limited to deep vein thrombosis (DVT), pulmonary embolism (PE), acute myocardial infarction, ischemic stroke, visceral vein thrombosis, or arterial embolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial objective response rate,iORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial progress-free survival ,iPFS;overall survival,OS; intracranial Duration of relief, iDOR;Safety of Treatment; | — |
Countries
China
Contacts
Public ContactZhang Xiaotao
Qingdao Centeral Hospital ,University of Health and Rehabilitation Sciences
Outcome results
None listed