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临床试验/NCT06699524
NCT06699524进行中(未招募)不适用

Construction of a Recurrence Risk Prediction Model for Liver Resection Based on Drug Sensitivity of Patient-derived Liver Cancer Organoid

Shen Feng1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2022年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
122
试验地点
1
主要终点
Recurrence free survival

研究概览

简要总结

Liver cancer is the sixth most common malignant tumor worldwide and the third leading cause of cancer-related deaths. China is a high-risk area for liver cancer, accounting for approximately 55% of primary liver cancer worldwide. Liver cancer is highly malignant and easy to recur, which seriously endangers the life and health of our people. Hepatectomy is the preferred treatment for liver cancer, but the 5-year recurrence rate remains as high as 70%, severely limiting the effectiveness of the surgery. Therefore, exploring the risk factors and predictive methods for early tumor recurrence after liver resection in patients has high clinical value. Clinical practice has found that primary liver cancer patients can be treated with postoperative adjuvant transarterial chemoembolization (TACE) to prevent recurrence. However, the effectiveness of TACE varies among patients and may be related to tumor heterogeneity. However, many studies have reported that drug sensitivity testing based on patient derived organoids can indicate the clinical efficacy of drugs, but there is currently no relevant research indicating that organoids can reflect the therapeutic response of TACE. Therefore, the aim of this study is to explore the correlation between patient derived organoid drug sensitivity testing results and TACE treatment responsiveness and tumor recurrence, and further construct a column chart model to predict tumor recurrence after adjuvant TACE.

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
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

drug-sensitive group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and < 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

干预措施: in vitro (chemotherapy) (Drug)

drug-sensitive group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and < 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

干预措施: Adjuvant TACE(Adjuvant Transarterial Chemoembolization) (Device)

drug-resistant group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and < 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

干预措施: in vitro (chemotherapy) (Drug)

drug-resistant group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and < 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

干预措施: Adjuvant TACE(Adjuvant Transarterial Chemoembolization) (Device)

结局指标

主要结局

Recurrence free survival

时间窗: Follow-up was performed at least every 2 months during the first 6 months after adjuvant TACE, and every 3 months for the subsequent 18 months. The follow-up period ended in September 2024

Recurrence within two years post-surgery was classified as early recurrence.

次要结局

未报告次要终点

研究者

发起方
Shen Feng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shen Feng

Dean of Clinical Research Institute, Director of Four Departments of Hepatology, Chief Physician, Professor

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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