NCT07613450尚未招募3 期
SYHA1813 vs Investigators' Choice Treatment in Patients With Recurrent or Progressive High-Grade Meningiomas: A Randomized, Controlled, Multicenter, Phase III Study
Shanghai Runshi Pharmaceutical Technology Co., Ltd0 个研究点目标入组 136 人开始时间: 2026年5月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
研究概览
简要总结
This is a randomized, controlled, open-label, multicenter, Phase III clinical study designed to compare the efficacy and safety of SYHA1813 versus treatment of investigators' choice in patients with recurrent or progressive high-grade meningioma not amenable to local therapy.
详细描述
Approximately136 participants with recurrent or progressive high-grade meningioma who have received surgical resection and radiotherapy will be enrolled and randomized 1:1 to receive either SYHA1813 (experimental group) or investigators' choice (control group) treatment. The primary endpoint is progression-free survival (PFS) assessed by blinded Independent Review Committee (BIRC) using the Response Assessment in Neuro-Oncology Working Group (RANO criteria) for meningioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Aged >= 18 years.
- •2. Histologically confirmed WHO grade II/III meningioma (WHO CNS 5th) that is progressive or recurrent.
- •3. Individuals must have received surgery and radiation therapy.
- •4. There is at least one measurable intracranial tumor lesion in the baseline period (RANO-meningioma).
- •6. The expected survival time is >=3 months.
- •7. The organ function level and related laboratory indicators must meet requirement.
- •8. Agree to use reliable and effective methods of contraception during the study treatment period and for at least 3 months after the last study treatment.
排除标准
- •1. Individuals who are known to have severe allergic reaction to the study drug or any other ingredients/excipients in the formulation.
- •2. Meets one of the following conditions: patients with brainstem involvement or extracranial metastasis; patients with severe brain herniation or at risk of brain herniation.
- •3. History of other malignant tumors within 3 years or concurrent active malignant tumors.
- •4. The toxic reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade
- •5. Have used potent inhibitors or inducers of CYP3A4, CYP2C19 or CYP1A2 within the 14 days prior to randomization or are still requiring continued use of such agents.
- •6. Individuals currently receiving warfarin or other oral anticoagulants (excluding those who use low-dose anticoagulants to maintain patency of central venous access or prevent deep vein thrombosis).
- •7. Individuals who are unable to undergo enhanced MRI (such as those with pacemakers, metal dentures, claustrophobia, contrast agent allergies, etc.).
- •8. Individuals with evidence or medical history of bleeding tendency within 2 months prior to randomization.
- •9. Individuals with urine protein ≥ 2+, and 24-hour quantitative urine protein ≥ 1.0 g/24 h upon testing.
- •10. History of acquired immunodeficiency syndrome or HIV antibody positivity in the past; Active hepatitis C; Active hepatitis B.
- •11. Individuals with poorly healing wounds or ulcers, or fractures that require treatment or exhibit poor healing.
- •12. Within 14 days prior to randomization, there were severe chronic or active infections (including tuberculosis infections) that required intravenous injection of antibacterial, antifungal or antiviral therapy.
- •13. Individuals with cardiovascular and cerebrovascular diseases of significant clinical significance.
- •14. Have undergone surgery of major vital organs within 28 days prior to randomization (excluding puncture biopsy).
- •15. Individuals with swallowing difficulties or known medication absorption disorders.
- •16. Pregnant or lactating women.
- •17. Any other conditions that may interfere with the participant's adherence to study procedures, compromise the participant's best interests in participating in the study, or affect study results.
研究者
相似试验
尚未招募
3 期
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering TherapyNCT07421284CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.900
招募中
3 期
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed HyperlipidemiaNCT07421297CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.760
已完成
2 期
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed HyperlipidemiaNCT07421232CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.156
尚未招募
2 期
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract CancerNCT07450976Suzhou Suncadia Biopharmaceuticals Co., Ltd.151
尚未招募
2 期
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast CancerBreast CancerNCT07416253Henan Cancer Hospital68