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NCT07160361Not yet recruitingPhase 4

Exploration of Postoperative Adjuvant Therapy for HCC Patients With Positive TB

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
56 (estimated)
First submitted
30 Aug 2025
Start date
1 Oct 2025
Primary completion date
31 Dec 2028
Lead sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
NCT number
NCT07160361

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 56
  • From 1 Oct 2025 to the primary completion date, 31 Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. before surgery

Other illness

  • Subjects with other malignant tumors;

Age

  • Subjects with incomplete medical record information (including gender, age, diagnostic information, imaging (and) or pathological diagnosis results, other demographic data, etc.).

Other

  • Hepatocellular carcinoma that cannot be surgically resected
  • Pregnant or lactating women
  • 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;

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.