NCT07478302招募中1 期
To Investigate the Pharmacokinetics, Safety, Tolerability and Efficacy of SHR-2524 Combined With Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC) in an Open-label, Multicenter Phase I Clinical Trial
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Trough serum concentrations (C21d)
研究概览
简要总结
This study was a multicenter, open-label phase I clinical trial. This trial will include 36 patients with advanced unresectable hepatocellular carcinoma. Blood samples were obtained during the course of treatment to measure the relative parameter. All Investigational Medicinal Products (IMP) were discontinued after the total cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥ 18 years old;
- •Advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or clinical diagnosis;
- •The Barcelona clinical liver cancer stage was B or C;
- •Has not previously received systemic antitumor therapy for HCC;
- •At least one measurable lesion according to RECIST v1.1 criteria;
- •Child-Pugh score of A or B7 ;
- •ECOG score 0 -1;
- •The expected survival time was ≥12 weeks;
- •The major organs functioned well;
- •Has signed the informed consent form.
排除标准
- •Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma confirmed by histology or cytology;
- •Patients with active malignant tumors other than HCC within 5 years or at the same time; Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, could be enrolled;
- •Previous allogeneic organ transplantation (e.g., liver transplantation);
- •The current liver tumor burden is greater than 50% of the total liver volume;
- •CTCAE grade 3 bleeding had occurred within 6 months or CTCAE grade 2 nongastrointestinal bleeding had occurred within 3 months before the first dose;
- •Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the first dose;
- •Major vascular disease had occurred within 6 months before the first dose;
- •Current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
- •Innate or acquired immune deficiency (such as HIV infection);
- •Severe infection occurred within 28 days before the first dose.
研究组 & 干预措施
SHR-2524 plus bevacizumab group
Experimental
SHR-2524 plus bevacizumab combined with other drugs.
干预措施: SHR-2524 Injection (Drug)
SHR-2524 plus bevacizumab group
Experimental
SHR-2524 plus bevacizumab combined with other drugs.
干预措施: Bevacizumab Injection (Drug)
结局指标
主要结局
Trough serum concentrations (C21d)
时间窗: 0 - 21 days.
Pharmacokinetics (PK) parameters.
Area under curve from Day 0 to Day 21 (AUC0-21d)
时间窗: 0 - 12 days.
Pharmacokinetics (PK) parameters.
Area under curve up to 21 weeks (AUC0-21weeks)
时间窗: 0 - 12 weeks.
Pharmacokinetics (PK) parameters.
次要结局
- Investigator - assessed progression-free survival (PFS) based on RECIST v1.1(About 9 months.)
- Geometric mean of the apparent volume of distribution of the population (Vz/F)(About 9 months.)
- The number and percentage of anti-drug antibody (ADA) positive participants(About 9 months.)
- Investigator - assessed overall survival (OS) based on RECIST v1.1(About 9 months.)
- Maximum blood concentration (Cmax)(About 9 months.)
- Time to peak concentration (Tmax)(About 9 months.)
- Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t)(About 9 months.)
- Area under curve - Time curve from Time 0 to Infinity (AUC0-∞)(About 9 months.)
- Elimination half-life (t1/2)(About 9 months.)
- Rate of clearance (CL/F)(About 9 months.)
- Adverse events (AEs)(About 9 months.)
- Serious adverse events (SAEs)(About 9 months.)
- Investigator - assessed objective response rate (ORR) based on RECIST v1.1(About 9 months.)
- Investigator - assessed duration of response (DoR) based on RECIST v1.1(About 9 months.)
- Investigator - assessed disease control rate (DCR) based on RECIST v1.1(About 9 months.)
研究者
研究点 (2)
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