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临床试验/NCT04290936
NCT04290936招募中4 期

Decreasing Risk of Recurrence by TAF in HCC Patients After Curative Treatment With Low HBV Viral Load

Taipei Veterans General Hospital, Taiwan4 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2020年10月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
402
试验地点
4
主要终点
Incidence of Hepatocellular carcinoma(HCC) recurrence

研究概览

简要总结

Hepatocellular carcinoma(HCC) is prevalent in the hepatitis B virus(HBV) infection endemic areas. For early stage of HCC, surgical resection, radiofrequency ablation (RFA) or microwave ablation (MWA) are the main treatment options. However, the risk of recurrence is as high as 50% in 5 years by surgical resection or 60-70% in 5 years by RFA. In average, the recurrence rate of HCC at 2 years is 30%. Many factors are associated with the HCC recurrence, including HBV viral load, cirrhotic stage, tumor size, tumor number, vascular invasion, alpha-fetoprotein(AFP) level and so on. Of them, high HBV viral load is associated with the risk of HCC recurrence after surgical resection, especially on late recurrence. In one previous randomized controlled trial, patients who received lamivudine, adefovir dipivoxil, or entecavir had significantly decreased early recurrence of HCC, however, whether nucleos(t)ide analogues(NUCs) can further reduce the risk of recurrence in patients with low viral loads (<2000 IU/ml) is still unclear.

In EASL 2017 guideline, all patients with compensated or decompensated cirrhosis need antiviral treatment, with any detectable HBV DNA level and regardless of alanine aminotransferase(ALT) levels. In Taiwan, even in chronic hepatitis B(CHB) infection patients with HCC, NUC is not reimbursed if their HBV viral load was less than 2000 IU/ml. It is an important unmet medical need to understanding the role of TAF in reducing the risk of recurrence in HBV-HCC patients with low HBV viral load (HBV DNA<2000 IU/ml) and significant liver fibrosis after curative treatment (The definition of significant liver fibrosis was based on reference. In our recent retrospective study, the risk of recurrence and survival are comparable between patients with and without NUCs treatment before HCC development only if NUCs treatment can be provided after curative treatment of HCC. However, a higher risk of recurrence was observed in cirrhotic patients with prior NUCs treatment before HCC occurrence. It would be interesting to investigate the incidence of recurrence by switching to tenofovir alafenamide(TAF) after curative treatment of HCC in patients already on NUCs treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HBsAg-positive for more than 6 months.
  • HCC after curative treatment (eight by surgical resection or RFA or MWA) with significant liver fibrosis (either by Ishak≧2, Metavir≧2, Knodell≧3) or cirrhosis and HBV DNA<2,000 IU/ml.
  • The duration of curative treatment of HCC to study enrollment should be less than 90 days.
  • Curative treatment is confirmed by contrast-enhanced CT or MR after the surgery/RFA/MWA.

排除标准

  • Child-Pugh class B8-C.
  • Active EV bleeding within 4 weeks.
  • History of hepatic encephalopathy or intractable ascites.
  • BCLC C or D.

研究组 & 干预措施

Arm 1

Experimental

NUC-naïve patients will be randomization into Tenofovir Alafenamide(TAF) treatment.

干预措施: Vemlidy® (Tenofovir Alafenamide; TAF) (Drug)

Arm 2

Placebo Comparator

NUC-naïve patients will be randomization into placebo arm.

干预措施: Placebo (Drug)

Arm 3

Active Comparator

NUCs-treated patients will be switched to Tenofovir Alafenamide(TAF) treatment.

干预措施: Vemlidy® (Tenofovir Alafenamide; TAF) (Drug)

结局指标

主要结局

Incidence of Hepatocellular carcinoma(HCC) recurrence

时间窗: Up to 2 years.

Incidence of HCC recurrence

次要结局

  • Hepatocellular carcinoma(HCC) recurrence in NUCs-treated patients after switched to TAF treatment(Up to 2 years.)
  • Dynamic (kinetics) changes in the bio-markers related to hepatitis B virus(HBV) infection(Up to 3 years.)
  • Changes in the renal function(Up to 3 years.)
  • Regression of liver fibrosis(Up to 3 years.)
  • Changes in the bone density(Up to 3 years.)
  • Hepatocellular carcinoma(HCC) recurrence(Up to 3 years.)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

vghtpe user

Yi-Hsiang Huang, M.D., Ph.D.

Taipei Veterans General Hospital, Taiwan

研究点 (4)

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