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临床试验/NCT04553458
NCT04553458已完成不适用

Factors Affecting Post-treatment Outcomes in Patients With Hepatocellular Carcinoma

Sohag University0 个研究点目标入组 407 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
407
主要终点
CURE (Number of patients cured completely from the disease)

研究概览

简要总结

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

详细描述

Background:

EASL and mRECIST criteria differ from each other in terms of the number of target lesions (all versus < = 2) and calculation method (bidimensional versus unidimensional). Therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (HCC) who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment outcomes.

Methods:

This work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. This study included patients that matched our eligibility criteria for a period of five years started from June 2015 to May 2020. The study purpose was to retrospectively analyze the clinical outcomes among patients with HCC who were treated with different modalities of therapy according to the BCLC classification, and detect the possible predictors of post-treatment favorable outcomes. The data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (SUH and SOI).

During the period of recruitment, 407 patients diagnosed with HCC admitted to our departments and followed-up attending outpatient clinics, Sohag University Hospitals, over a 5 years period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Adult patients
  • with hepatocellular carcinoma

排除标准

  • severely-ill patients
  • With other system comorbidities,
  • presence of extrahepatic metastasis,
  • patients who dropped from the follow-up list after treatment.

研究组 & 干预措施

Favorable outcome

Cure or stable disease

干预措施: Trance-arterial chemoembolization (Drug)

Favorable outcome

Cure or stable disease

干预措施: Radiofrequency ablation (Device)

Favorable outcome

Cure or stable disease

干预措施: Liver resection (Procedure)

Favorable outcome

Cure or stable disease

干预措施: Combined radiofrequency ablation + percutaneous ethanol injection (Combination Product)

Favorable outcome

Cure or stable disease

干预措施: Percutaneous ethanol injection (Drug)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Radiofrequency ablation (Device)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Trance-arterial chemoembolization (Drug)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Combined radiofrequency ablation + percutaneous ethanol injection (Combination Product)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Percutaneous ethanol injection (Drug)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Systemic chemotherapy (Drug)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Sorafenib (Drug)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Viscum (Dietary Supplement)

Unfavorable outcome

Progressive (deteriorate/Recurrence) or Death

干预措施: Symptomatic treatment (Drug)

结局指标

主要结局

CURE (Number of patients cured completely from the disease)

时间窗: one-year

the HCC is treated (disappearance of all lesions)

STABLE Disease (Number of patients with neither progression nor cure from the disease)

时间窗: one-year

NONE of the other outcomes' criteria

PROGRESSIVE((Number of patients with progression of the disease) (measured by follow-up CT scans, increase in size, appearance of new intratumoral lesions, or appearance of new lesions

时间窗: one-year

increase in size - appearance of new intratumoral lesions - new lesions

次要结局

  • DEATH (Number of patients died from the disease)(one-year)

研究者

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

Emad Ali Ahmed Ali

Principal investigator

Sohag University

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