2024-517331-48-00
尚未招募
3 期
A Multi-Center, Double-Blind, Randomized, Phase III Study to Investigate the Efficacy and Safety of CS1003 in Combination with Lenvatinib Compared to Placebo in Combination with Lenvatinib as First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma (HCC)
Cstone Pharmaceuticals (Suzhou) Co. Ltd.6 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2024年10月29日最近更新:
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Cstone Pharmaceuticals (Suzhou) Co. Ltd.
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Overall survival
概览
简要总结
To compare the efficacy of CS1003 in combination with lenvatinib vs.placebo in combination with lenvatinib
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •1.Age ≥18 years on the day of signing informed consent (For Taiwan, the lower limit of age is 20 years). 2.Subjects with unresectable advanced HCC that is not eligible for surgery and/or locoregional therapy (Stage B or C based on Barcelona Clinic Liver Cancer [BCLC] staging system) and meets either one of the following criteria: 1) histologically or cytologically confirmed diagnosis of HCC, 2) clinically confirmed diagnosis of HCC according to American Association for the study of Liver Diseases (AASLD) criteria.
- •With at least one measurable lesion can be assessed.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or
- •Life expectancy ≥ 3 months.
- •Child-Pugh A.
- •No prior systemic treatment for advanced HCC.
- •Subjects with hepatitis B virus (HBV) infection are willing to continue receiving antiviral treatment while on study.
- •Subjects have adequate organ and marrow function.
- •Female subjects with childbearing potential must have negative serum pregnancy test result at screening. Female subjects with childbearing potential, and male subjects and their female partners with childbearing potential must agree to use a contraceptive method(s) detailed in the protocol from the day of signing informed consent form (ICF), during the study and till at least 6 months after the last dose.
排除标准
- •1.Fibrolamellar HCC, sarcomatoid HCC, cholangiocellular carcinoma or mixed cholangiocarcinoma and HCC.
- •A prior bleeding event due to esophageal or gastric varices within 6 months or other gastrointestinal bleeding events within 28 days prior to screening. Untreated or incompletely treated esophageal or gastric varices that are considered by the investigator to be at high-risk for bleeding (Note: Patients must undergo an esophagogastroduodenoscopy [EGD], and all size of varices [small to large] must be assessed and treated per local standard of care prior to enrollment; patients who have undergone an EGD within 6 months prior to the initiation of study treatment do not need to repeat the procedure). Active gastric or duodenal ulcer.
- •Malabsorption syndrome or inability to take oral medication due to other causes.
- •HBV and HCV co-infection.
- •Surgery or locoregional therapy for palliative purpose (e.g., to treat bone metastases or metastases causing nerve impingement) within 4 weeks prior to study treatment.
- •History of other malignancy(ies) in the past 5 years, except for malignant disease treated with curative intent and without active disease.
- •Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- •Current or prior use of systemic corticosteroid (> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study treatment.
- •History of bone marrow transplantation or organ transplantation.
- •History of anaphylaxis or hypersensitivity to any ingredient of the investigational product.
结局指标
主要结局
Overall survival
Overall survival
次要结局
- Objective response rate
研究者
Seema Harrar
Scientific
Cstone Pharmaceuticals (Suzhou) Co. Ltd.
研究点 (6)
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