Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB

Xi'an Jiaotong University

Status and phase

Not yet enrolling

Phase 4

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: Lenvatinib + losartan

Study type

Interventional

Funder types

Other

Identifiers

NCT07160361

XJTUSAH-TB-Z008

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;

Exclusion criteria

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.).