NCT04784520终止2 期
A Multicentre, Open-label, Single-arm Phase II Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (BTC)
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年6月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- progression-free survival
研究概览
简要总结
This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC). A total of approximately 30 subjects with advanced BTC will be enrolled. The subjects will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 600 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first.
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
- •Be willing to participate in the clinical trial and sign the informed consent;
- •Histologically/cytologically confirmed unresectable locally advanced or metastatic BTC (including cholangiocarcinoma or gallbladder cancer) with failure of or intolerance to the prior therapy (including disease progression within 6 months after adjuvant chemotherapy) and with at least one measurable lesion based on RECIST 1.1 criteria;
- •Aged 18 to 75 years (inclusive);
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;
- •Routine blood test results must meet the following criteria without blood transfusion within 14 days: 1) Hemoglobin (Hb)≥90 g/L; 2) Absolute neutrophil count (ANC)≥1.5 x 10^9/L; 3) Platelet count (PLT)≥75×10^9/L;
- •Coagulation test results must meet the following criteria: International Normalized Ratio (INR) <1.5 or Activated Partial Thromboplastin Time (APTT) <1.5×ULN;
- •Other laboratory test results must meet all the following criteria: 1) Total bilirubin (TBIL)≤1.5×ULN, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN (TBIL≤3×ULN, ALT and AST≤5×ULN in the subjects with liver metastasis); 2) Serum creatinine≤1.5×ULN；3) Serum albumin≥28g/L;
- •Male and female subjects of childbearing potential must agree to take effective contraception for the duration of treatment and for 6 months after completion of study drug administration; female subjects must have negative results of serum/urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.
排除标准
- •Subjects with ampullary carcinoma;
- •Subjects who had participated in other clinical trials and received the treatment within 4 weeks prior to enrolment;
- •The time interval between the end of the last antitumor treatment and the first administration of HA121-28 tablets < 4 weeks (for any antitumor treatment, including but not limited to chemotherapy, radiotherapy and targeted therapy), or < 2 weeks (for local palliative radiotherapy for pain relief or traditional Chinese medicine with approved indications for cancer);
- •Urine protein≥2+ and urine protein > 1.0g/24h;
- •History of other malignancies within the past 5 years prior to enrolment, except for cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumor, and early esophageal and gastrointestinal cancers that were confined to the mucosal layer and resected under endoscopy;
- •History of any solid-organ or bone-marrow transplantation (except the transplantation without immunosuppression such as corneal and hair transplantation);
- •Unremitted toxic reaction>grade 1 due to any previous treatment at the time of enrollment (except for hair loss and pigmentation) which is considered to influence the safety evaluation;
- •ECG meets one of the following criteria: 1) QT/QTc interval≥450ms, congenital long QT syndrome (LQTS) or family history of LQTS; 2) any clinically significant abnormalities of rhythm, conduction or morphology in the resting ECG requiring therapeutic intervention;
- •Left ventricular ejection fraction (LVEF) <50% in echocardiogram;
- •Severe concomitant diseases which may have influence on the safety of the subjects or the completion of the study based on the investigator' judgement such as uncontrolled hypertension (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg after treatment);
- •High risk factors of gastrointestinal diseases such as gastrointestinal perforation and abdominal fistula;
- •Subjects with spinal cord, meningeal or brain metastasis (except for asymptomatic or stable brain metastasis within 4 weeks prior to administration);
- •Subjects with hepatopathy meet one of the following criteria: 1) HBsAg positive and HBV DNA >2000 IU/mL（or >1×10^4 copies/mL）; 2) HCV antibody positive and HCV RNA positive; 3) cirrhosis;
- •HIV antibody positive;
- •Subjects have history of surgery within 4 weeks prior to administration or have not been recovered from any previous invasive procedure, except for biliary stenting, biliary drainage, etc.;
- •Not suitable for the study in the investigator's opinion.
研究组 & 干预措施
HA121-28 tablets
Experimental
HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)
干预措施: HA121-28 tablets (Drug)
结局指标
主要结局
progression-free survival
时间窗: Approximately 3.5 years
次要结局
- disease control rate(Approximately 3.5 years)
- objective remission rate(Approximately 3.5 years)
- overall survival(Approximately 3.5 years)
- duration of response(Approximately 3.5 years)
研究者
研究点 (2)
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