NCT06413745进行中（未招募）2 期
A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- ORR evaluated by IRC according to RECIST v1.1 standard
研究概览
简要总结
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old ( including both ends ), male or female ;
- •ECOG-PS score : 0 or 1;
- •Expected survival ≥ 12 weeks;
- •Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
- •Subjects who failed or intolerance after systemic chemotherapies;
- •According to the RECIST v1.1 standard, the subjects had at least one measurable lesion；
- •The main organ function is normal, in line with the program requirements ;
- •If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be < 500 IU / mL；
- •Consent to contraception.
排除标准
- •Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- •Subjects with a history or evidence of brain metastasis or meningeal metastasis ;
- •With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ;
- •Severe trauma or major surgery was performed within 4 weeks before the first administration;
- •To study the severe heart disease within 6 months before the first administration ;
- •Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ;
- •Severe infection symptoms occurred within 2 weeks before the first administration;
- •Known hereditary or acquired bleeding and thrombotic tendency ;
- •Congenital or acquired immune defects;
- •The subjects had severe and uncontrollable concomitant diseases;
- •Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study;
研究组 & 干预措施
SHR-A1811
Experimental
干预措施: SHR-A1811 (Drug)
结局指标
主要结局
ORR evaluated by IRC according to RECIST v1.1 standard
时间窗: About a year
次要结局
- DoR evaluated by the researchers according to the RECIST v1.1 standard(About a year)
- AE(About a year)
- DCR evaluated by IRC according to RECIST v1.1 standard(About a year)
- DCR evaluated by the researchers according to the RECIST v1.1 standard(About a year)
- SAE(About a year)
- DoR evaluated by IRC according to RECIST v1.1 standard(About a year)
- ORR evaluated by the researchers according to the RECIST v1.1 standard(About a year)
- PFS evaluated by the researchers according to the RECIST v1.1 standard(About a year)
- OS(About two year)
- PFS evaluated by IRC according to RECIST v1.1 standard(About a year)
研究者
研究点 (1)
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