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临床试验/NCT07321613
NCT07321613已完成不适用

Effect of Thalidomide, Carmofur and Compound Mylabris Capsules (TCC) Cocktail Combined With Transarterial Chemoembolization Versus Transarterial Chemoembolization Alone on Survival in Patients With Unresectable Hepatocellular Carcinoma

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 545 人开始时间: 2023年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
545
试验地点
1
主要终点
Overall Survival (OS)

研究概览

简要总结

This is a multicenter, retrospective cohort study that aims to evaluate the efficacy and safety of a triple-drug cocktail (TCC), consisting of Thalidomide, Carmofur, and Compound Mylabris Capsules (CMC), in combination with conventional Transarterial Chemoembolization (TACE) for the treatment of patients with unresectable Hepatocellular Carcinoma (HCC).

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

  • patients who met the HCC diagnostic criteria according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China.
  • patients underwent conventional TACE.
  • availability of complete medical records for data extraction and follow-up.

排除标准

  • a history of previous or synchronous treatment for tumors such as radio frequency ablation (RFA) or systemic chemotherapy.
  • poor liver functions (Child-Pugh class C).
  • accompanying other life-threatening diseases.

研究组 & 干预措施

TACE+cocktail

Patients in the TACE+cocktail group received TACE and took the combined oral medications daily, which consisted of thalidomide tablets, carmofur tablets , and compound mylabris capsule.

干预措施: Thalidomide (50mg) (Drug)

TACE+cocktail

Patients in the TACE+cocktail group received TACE and took the combined oral medications daily, which consisted of thalidomide tablets, carmofur tablets , and compound mylabris capsule.

干预措施: carmofur (Drug)

TACE+cocktail

Patients in the TACE+cocktail group received TACE and took the combined oral medications daily, which consisted of thalidomide tablets, carmofur tablets , and compound mylabris capsule.

干预措施: compound mylabris capsule (Drug)

TACE+cocktail

Patients in the TACE+cocktail group received TACE and took the combined oral medications daily, which consisted of thalidomide tablets, carmofur tablets , and compound mylabris capsule.

干预措施: TACE (Procedure)

TACE only

Patients in the TACE only group received only TACE treatment.

干预措施: TACE (Procedure)

结局指标

主要结局

Overall Survival (OS)

时间窗: up to five years

Defined as the time interval from the date of the patient's first TACE treatment to the date of death from any cause or the date of the last follow-up (whichever occurred first).

次要结局

  • Objective Response Rate (ORR) at 6 Months(up to six months)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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