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This is a randomized, controlled, open-label, multicenter, Phase II clinical study designed to evaluate the efficacy and safety of SYHA1813 compared to investigators' choice in participants with recurrent or progressive high-grade meningioma.
A total of 56 participants with recurrent or progressive high-grade meningioma who are not eligible for local therapy will be enrolled. Participants will be randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group). The primary endpoint is the 6-month progression-free survival (PFS) rate assessed by investigators using the Response Assessment in Neuro-Oncology Working Group( RANO criteria) for meningioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | SYHA1813 |
|
| Control group | Active Comparator | Investigator's Choice Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYHA1813 | Drug | The starting dose of SYHA1813 is 20mg QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the Progression-free survival (PFS) at 6-month(PFS-6)as evaluated by investigator (RANO-meningioma) | Up to approximately 3years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) as evaluated by INV (RANO-meningioma) | Up to approximately 3years | |
| Objective response rate (ORR) as evaluated by INV (RANO-meningioma) | Up to approximately 3years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a randomized, controlled, open-label, multicenter, Phase II clinical trail, randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group).
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| Investigator's Choice Treatment |
| Drug |
Investigator's Choice Treatment |
|
| Disease control rate (DCR) as evaluated by INV (RANO-meningioma) | Up to approximately 3years |
| Overall survival (OS) | Up to approximately 3years |
| Frequency and severity of TEAE and SAE | Up to approximately 3years |
| Maximum Plasma Concentration of SYHA1813 (Cmax) | Up to approximately 3years |
| The scores of the 30-item European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) | The EOTCT QLQ-C30 is designed to measure the health-related quality of life (HRQoL) across different cancer types and stages. It has demonstrated good evidence of content validity for assessing functional health, symptom burden, and health-related quality of life in patients with localized to advanced cancer. The questionnaire comprises 30 items that are combined to form five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), and six single items (appetite loss, diarrhea, constipation, dyspnea, insomnia, and financial difficulties), as well as a global health status/quality of life scale. The global health status scale is scored on a 7-point scale, while the other items are scored on a 4-point scale. Higher scores indicate a higher level of response. | Up to approximately 3years |
| The scores of the 20-item EORTC QLQ for Brain Neoplasm (-BN20) | The EORTC QLQ-BN20 is a 20-item questionnaire specifically designed for assessing the health-related quality of life (HRQOL) and symptoms in patients with brain cancer, including both primary brain tumors and brain metastases. Within the EORTC framework, there is a distinction between functional scales (e.g., "Emotional Functioning") and symptom scales (e.g., "Pain"). High scores on functional scales indicate better functioning, while high scores on symptom scales indicate a greater symptom burden. | Up to approximately 3years |
| The score of The Neurologic Assessment in Neuro-Oncology (NANO) scale | The NANO scale evaluates 9 major domains of neurologic function that are most relevant to patients with supratentorial, infratentorial, and brainstem tumors, including gait, strength, upper extremity ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior. As designed, the gait domain includes assessment of lower extremity ataxia. Each domain is subdivided into 3 or 4 levels of function with scores based on discrete quantifiable measures. Thus, levels of function for each domain range from 0 to 2 or 0 to 3. A score of 0 indicates normal function, while the highest score indicates the most severe level of deficit for that domain. Levels of function are distinguished by significant and measurable differences in order to avoid misinterpretation of subtle or nonspecific changes. | Up to approximately 3years |