Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Lenvatinib + losartan

Treatment groups

56 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Second Affiliated Hospital of Xi'an Jiaotong University

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Shaanxi Provincial People's Hospital

Collaborator

Affiliated Hospital of Qinghai University

Collaborator