Trial · NCT07037238
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) assessed by MRI | 1 year | |
| Secondary | Duration of Response (DOR) and 1-year DOR rate assessed by MRI | 1 year | |
| Secondary | Mean Percentage Reduction in Target Lesion Volume at 3, 6, and 12 Months Assessed by MRI | 1 year | |
| Secondary | Changes in Perilesional Microbleeds and Iron Deposition at 3, 6, and 12 Months Assessed by MRI QSM Sequence. | 1 year | |
| Secondary | Changes in lesion hemorrhage risk during the follow-up period | 1 year | Based on MRI, imaging evidence of hemorrhage was defined as changes meeting the following criteria: (1) an increase in lesion size or alteration in its shape; and (2) a change in signal intensity, primarily characterized by a shift from hypointensity to hyperintensity, especially on T1-weighted sequences. Hemorrhage rates were calculated at 3, 6, and 12 months during follow-up to comprehensively evaluate the temporal changes in hemorrhagic risk of the lesion. |
| Secondary | The frequency and severity of intracranial hemorrhage events during the follow-up period were assessed through clinical records, imaging examinations (MRI), and the mRS scoring system. | 1 year | |
| Secondary | Changes in patients' clinical signs and symptom scores from baseline. | 1 year | The effectiveness of the medication and patient prognosis were comprehensively assessed by comparing the clinical symptoms and mRS scores of patients after treatment with baseline clinical symptoms and mRS scores. The mRS scale ranges from 0 to 5, with a decrease in score indicating a more favorable prognosis. |
| Secondary | Disease Control Rate (DCR) assessed by MRI | 1 year | |
| Secondary | Progression-Free Survival (PFS) and 1-year PFS rate assessed by MRI | 1 year | |
| Secondary | The frequency and types of seizures during the follow-up period were recorded and assessed through seizure event logs and classification of seizure types. | 1 year | |
| Other | Incidence of Treatment-Emergent Adverse Events | 1year | The type and frequency of treatment-emergent adverse events (TEAEs) occurring during the treatment period, evaluated according to NCI-CTCAE version 5.0;Treatment-related TEAEs;Serious adverse events (SAEs);TEAEs leading to permanent discontinuation of treatment;Incidence and frequency of death occurring within 30 days after the last dose of treatment;Laboratory abnormalities assessed according to NCI-CTCAE version 5.0. |
| Other | Changes in patients' FACIT scores during the follow-up period | 1year | The change in the patient's quality of life compared to baseline was primarily assessed using the Functional Assessment of Chronic Illness Therapy (FACIT) system. The score ranges from 0 to 108, and the scale is divided into four parts: Physical Well-Being (PWB), Social and Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). Among these, lower scores in Physical Well-Being and Emotional Well-Being indicate better quality of life and prognosis, while higher scores in Social and Family Well-Being and Functional Well-Being indicate better quality of life and prognosis. |
| Other | Pharmacokinetic (PK) profile/parameters | 1 year | In this study, we will evaluate the pharmacokinetic (PK) profile of the drug by measuring "peak plasma concentration (Cmax)" over the one-year treatment period to assess the drug's metabolic behavior. |
| Other | Pharmacokinetic (PK) profile/parameters | 1 year | In this study, we will assess the pharmacokinetic (PK) profile of the drug by measuring the area under the plasma concentration versus time curve (AUC) over the one-year treatment period to evaluate the drug's metabolic characteristics. |
| Other | Changes in patients' mRS scores during the follow-up period | 1year | The change in the patient's quality of life compared to baseline was primarily assessed using the Modified Rankin Scale (mRS) score. The mRS score ranges from 0 to 5, with lower scores indicating better functional status, higher quality of life, and a better prognosis. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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