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临床试验/NCT07160361
NCT07160361尚未招募4 期

Exploration of Postoperative Adjuvant Therapy for Hepatocellular Carcinoma Patients With Positive Tumor Budding

Second Affiliated Hospital of Xi'an Jiaotong University0 个研究点目标入组 56 人开始时间: 2025年10月1日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
56
主要终点
Relapse rate within 2 years

研究概览

简要总结

Hepatocellular carcinoma (HCC) is one of the most common types of primary liver cancer worldwide, characterized by complex and variable disease progression and significant treatment challenges. Among HCC patients, tumor budding (TB) is associated with a high risk of postoperative recurrence, significantly impacting patient prognosis. Even in the current HCC pathological diagnosis "gold standard" of MVI-negative patients, TB retains excellent prognostic predictive value. TB cells reside within the peritumoral stroma, where dense collagen fibers restrict the efficacy of therapeutic agents including chemotherapy, immunotherapy, and targeted therapies, making it difficult for single-agent treatments to effectively eliminate TB. Therefore, specific treatment strategies should be considered for TB-positive patients to improve survival outcomes and reduce the risk of tumor recurrence. To address this clinical challenge, this study aims to clarify the prognostic impact of combining collagen degradation therapy with targeted therapy in TB-positive HCC patients. Through a single-arm trial (postoperative targeted therapy + collagen degradation therapy), investigators explore the clinical efficacy and prognostic indicators of this combination approach, seeking the optimal treatment strategy for TB-positive HCC patients. Collagen degradation therapy facilitates drug delivery to tumor-bottle lesions by degrading collagen barriers, while targeted therapy specifically intervenes against cancer cells. Their combination holds promise for synergistic effects and enhanced therapeutic outcomes. This study aims to preliminarily assess the impact of this dual approach on prognosis, providing evidence for personalized treatment strategies. The findings of this research hold promise for delivering new breakthroughs in the treatment of TB-positive HCC patients, improving their quality of life and survival rates, and providing robust support for future clinical practice.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Age is ≥18 years old, male or female;
  • Histologically confirmed as hepatocellular carcinoma without metastasis;
  • Tumor budding is positive
  • Life expectancy of at least 12 weeks;

排除标准

  • Hepatocellular carcinoma that cannot be surgically resected
  • Received radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. before surgery
  • Pregnant or lactating women
  • Subjects with other malignant tumors;
  • Subjects who are considered unsuitable to participate in this cohort study by the investigator;
  • Subjects who refuse to enroll or do not sign the informed consent form;
  • Subjects with incomplete medical record information (including gender, age, diagnostic information, imaging (and) or pathological diagnosis results, other demographic data, etc.).

研究组 & 干预措施

Lenvatinib + losartan treatment group

Experimental

干预措施: Lenvatinib + losartan (Drug)

结局指标

主要结局

Relapse rate within 2 years

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital of Xi'an Jiaotong University
申办方类型
Other
责任方
Sponsor

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