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临床试验/NCT04048317
NCT04048317Unknown早期 1 期

Effectiveness of Drug Eluting & Conventional Trans-arterial Chemo-embolization in Treatment of Primary Hepatic Cell Carcinoma

Assiut University0 个研究点目标入组 75 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
75
主要终点
Evaluate the effectiveness of drug-eluting bead trans-arterial chemo-embolization in patients of hepatocellular carcinoma

研究概览

简要总结

the aim of this work to compare effectiveness of drug-eluting bead trans-arterial chemo-embolization and conventional trans-arterial chemo-embolization of hepatic cell carcinoma in the aspect of (Tumor response via m-RECIST criteria), (liver injury via Liver function tests and tumor markers) and (survival outcome) of patients treated in Assiut university .

详细描述

Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world and the third most common cause of cancer-related death .. With improved surveillance of patients with chronic liver disease and advances in imaging, more patients are diagnosed with early-stage HCC . For the treatment of early stage HCC, curative therapies including liver transplantation, hepatic resection, and radio frequency ablation (RFA) are recommended. Liver transplantation is the treatment option especially for patients with decompensated cirrhosis, but potential recipients outnumber donors. Hepatic resection is widely used as the main choice of treatment for resectable HCC. However, the risk of postoperative hepatic dysfunction often precludes surgery.

For unresectable patient, trans-arterial chemo-embolization (TACE) was the treatment of choice .

At 2014, Yang et al. compared the treatment effects of hepatic resection, RFA, and conventional TACE on long-term survival. It was found that the range of patients treated by TACE in clinical practice reported survivals widely range from 8-26% at 5-years. which was similar to that with hepatic resection and RFA in patients with single-nodule HCC of 3 cm or smaller without vascular invasion when the underlying liver status was balanced among the patients receiving each treatment. In addition, most of the patients initially treated with c-TACE achieved a complete response, which was one of the independent prognostic factors of survival, although some should receive repeated treatments. However, when c-TACE is used as an initial treatment, special care should be taken to obtain a complete response, and surveillance for tumor recurrence should be undertaken. These results are consistent with those of cohort studies demonstrating that TACE provided overall survival similar to hepatic resection in early-stage HCC .

Conventional (Lipiodol) TACE Base on technique with emulsified combination of chemotherapy such as Doxorubicin and Lipiodol administrate via arterial feeder.

Less in systemic chemotherapy and increase overall survival rate were the most concern in treatment but many studies reported side effects from conventional (Lipiodol) TACE significantly among an improvement of overall survival rate .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

入选标准

  • patients must be 18 to 75 years old.
  • patients must be diagnosed as primary Hepatocellular carcinoma (HCC) by radiologic imaging revealed angiogenicity pattern .
  • All of the patient have Child-Pugh status A or B .
  • All of the patient have BCLC stage A or B.
  • patients must have adequate renal and liver function accepting the maneuver.
  • patients must have adequate coagulation profile (platelets count ≥ 80 000), (prothrombin concentration ≥ 70 %).
  • patients must haven't previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation).

排除标准

  • patients have previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation).
  • patients with impaired coagulation profile (platelets count < 80 000), (prothrombin concentration < 70 %).
  • patients with decompensated liver cell failure having ascites which impedes the maneuver .
  • patients with past history of reaction to the drug used in maneuver
  • patients with poor image quality.
  • patients with lost follow up .

研究组 & 干预措施

drug eluting bead trans arterial chemo embolization

Experimental

the international arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Hepasphere

干预措施: HepaSphere Microspheres/Doxorubicin Hydrochloride (Drug)

conventional trans arterial chemo embolization

Placebo Comparator

the control arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Lipiodol

干预措施: Lipiodol (Drug)

结局指标

主要结局

Evaluate the effectiveness of drug-eluting bead trans-arterial chemo-embolization in patients of hepatocellular carcinoma

时间窗: baseline

Evaluate the efficacy and safety of drug-eluting bead trans-arterial chemo-embolization in management of HCC patients in comparison of conventional chemo-embolization in 75 stable patients by evaluating the response of embolized lesions for each drug with modified RECIST criteria.

次要结局

未报告次要终点

研究者

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

Ahmed Mohammed Hassan Taha Abdurabou

Resident radiologist

Assiut University

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