Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB

NCT ID: NCT07160361

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2029-12-31

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenvatinib + losartan treatment group

Group Type: EXPERIMENTAL

Lenvatinib + losartan

Intervention Type: DRUG

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 daily starting postoperatively.

Interventions

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 daily starting postoperatively.

Intervention Type: DRUG

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Qinghai University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Kai Qu

Role: CONTACT

qukai001@xjtu.edu.cn

+8613609117104

Other Identifiers

XJTUSAH-TB-Z008

Identifier Type: -

Identifier Source: org_study_id