A Phase I/II Randomized, Double-blinded Study of FB-1603 to Evaluate the Safety and Efficacy in Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization (FECHT Trial)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in the level of liver function
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of FB-1603 on improving liver function impairment in hepatocellular carcinoma patients receiving transarterial chemoembolization. The main question it aims to answer is:
Changes in the level of liver function parameters, including AST, ALT, or total bilirubin, from baseline to Visit 3, Visit 4, Visit 5, and Visit 6
There is a comparison group: Researchers will compare arm 1 placebo to see if FB-1603 is work to treat the liver function.
Participants will
- Take drug FB-1603 990mg/day, FB-1603 1980mg/day or a placebo every day for 10 weeks.
- Visit the clinic on day 4, 7, 10, 14, 28, 56 and 84 (follow-up)
详细描述
I. Objectives:
-
Primary objective: To assess the efficacy of FB-1603 on improving liver function impairment after transarterial chemoembolization (TACE) in subjects
-
Secondary objective:
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To evaluate the safety of FB-1603 in subjects
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To evaluate selected parameters indicative of clinical efficacy
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To assess postembolization syndrome improvement of FB-1603 compared with placebo
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To evaluate virologic test level of FB-1603 compared with placebo
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To assess liver stiffness change of FB-1603 compared with placebo
-
Exploratory objective:
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To assess the antioxidation activity of FB-1603 in hepatocellular carcinoma (HCC) subjects after TACE
II. Investigational product:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-85 years (inclusive) of either gender
- •Willing and able to provide signed informed consent
- •Confirmed diagnosis of hepatocellular carcinoma by radiology, histology, or cytology
- •Subject has the willingness to undergo TACE
- •ECOG performance Status of 0-1
- •The patient is expected to survive more than 3 months
- •Laboratory values should meet all the following standards at the screening visit:
- •A. AST, ALP and ALT are ≤ 5x ULN. B. International Normalized Ratio (INR) ≤ 1.5 C. Prothrombin time < 4 sec above upper limit of normal D. Absolute neutrophil count ≥ 1.5×10^9/L; Hemoglobin ≥ 9 g/dL; platelet ≥ 50×10^9/L.
- •E. Total bilirubin < 2.5 mg/dL F. Serum creatinine < 2 mg/dL
- •With liver stiffness measurement >7 kPa (assessed by FibroScan®) or > 1.5 m/sec (assessed by acoustic radiation force impulse elastography (ARFI))
排除标准
- •Patients with evidence of macrovascular invasion
- •Patients with evidence of extrahepatic spread
- •Any condition representing a contraindication to TACE as determined by the investigators
- •Acute liver failure or liver function decompensation patient perform, such as hepatic encephalopathy, and ascites
- •Patients with acute or chronic active hepatitis B or C infection and are recommended to receive HBV or HCV treatment, e.g., Patient with HBV DNA ≥ 20,000 IU/ml or with detectable HCV RNA
- •Patients who have severe organic diseases on heart, lungs, brain, kidney, and gastrointestinal tract by the judgment of investigators
- •Patients with chronic pancreatitis
- •Patients who are taking any prohibited drugs that might interfere the trial
- •Patients who are not able to express the chief complaint, for example, the patients with psychosis and severe neurosis
- •Patients with active infections (infection requiring the use systemic antibiotics) within 4 weeks prior to the screening visit
研究组 & 干预措施
low dose FB-1603 (990mg/day)
2*FB-1603 165 mg oral capsule and 2*Placebo oral capsule each time, TID (990 mg/day). treatment period: start two weeks before TACE until eight weeks after TACE.
干预措施: FB-1603 (Drug)
low dose FB-1603 (990mg/day)
2*FB-1603 165 mg oral capsule and 2*Placebo oral capsule each time, TID (990 mg/day). treatment period: start two weeks before TACE until eight weeks after TACE.
干预措施: Placebo (Drug)
high dose FB-1603 (1980mg/day)
4*FB-1603 165 mg oral capsule each time, TID (1980 mg/day). treatment period: start two weeks before TACE until eight weeks after TACE.
干预措施: FB-1603 (Drug)
placebo
4*Placebo oral capsule each time, TID (three times a Day). treatment period: start two weeks before TACE until eight weeks after TACE.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the level of liver function
时间窗: from baseline (day 0) to Visit 3 (day 4), Visit 4(day 7), Visit 5(day 10), and Visit 6(day 14)
Changes in the level of liver function parameters, including aspartate transferase (AST), alanine transferase (ALT), or total bilirubin,
次要结局
- Frequency and severity of adverse event (AE) during the study(up to 84 days)
- Clinically significant changes in blood chemistry(from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28), Visit 8 (day 56) and follow-up visit (day 84))
- Clinically significant changes in coagulation test(from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28), Visit 8 (day 56) and follow-up visit (day 84))
- Changes in the level of liver function(from baseline (day 0) to Visit 7 (day 28) and Visit 8 (day 56))
- Incidence of postembolization syndrome(from baseline (day 0) to Visit 3 (day 4), Visit 4 (day 7), Visit 5 (day 10), Visit 6 (day 14), Visit 7 (day 28) and Visit 8 (day 56))
- Length of hospital stay after TACE(Visit 2 (day 0))
- Changes in measurements of indocyanine green retention (ICG)(from baseline (day 0) to Visit 3 (day 4) and Visit 5 (day 10))
- Level of liver fibrosis(at the screening visit (day -28 to -15), Visit 8 (day 56) and FV/ET (day 84))
- Changes in the level of quantitative HBsAg or HCV RNA(from screening visit (day -28 to -15) to Visit 8 (day 56) and FV/ET (day 84))