Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lenvatinib + losartan.
- Who it may be relevant to
- Registry conditions: Carcinoma, Hepatocellular. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploration of Postoperative Adjuvant Therapy for Hepatocellular Carcinoma Patients With Positive Tumor Budding
Overview
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.
Interventions
- Drug Lenvatinib + losartan
Patients will receive a combination of lenvatinib and losartan at the same time after surgery for treatment cycles once daily (lenvatinib and losartan). Adjuvant therapy will be started within 2-6 weeks after surgery for a period of time to evaluate the effect of different treatment regimens on reducing tumor recurrence and improving survival. lenvatinib: orally once daily according to standard dosing guidelines, starting postoperatively. losartan: 50mg losartan potassium tablets orally once
Primary outcome measures
- Relapse rate within 2 years [Time frame: 2 years]
Eligibility criteria
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07160361 · XJTUSAH-TB-Z008