Targeted therapy after surgery for liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a combination of PD-1 monoclonal antibody and lenvatinib as adjuvant therapy for patients with hepatocellular carcinoma (HCC) who exhibit a specific vascular pattern known as VETC. Previous research indicates that VETC-positive patients have a higher risk of postoperative recurrence, and this study aims to validate the therapeutic approach to improve their prognosis. By enrolling patients who meet specific criteria, the study will assess the impact of the treatment on recurrence rates and overall survival. This multicenter prospective cohort study is designed to provide insights into effective treatment strategies for this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-75.
2. No previous local or systemic treatment for hepatocellular carcinoma.
3. Child-Pugh liver function score ≤ 7.
4. ECOG PS 0-1.
5. No serious organic diseases of the heart, lungs, brain, kidneys, etc.
6. Pathologic type is hepatocellular carcinoma.
7. Confirmation of the presence of VETC vascular pattern by CD34 immunohistochemical staining.

Exclusion Criteria:

1. Pregnant and lactating women.
2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
4. Active infection.
5. Other significant clinical and laboratory abnormalities that affect the safety evaluation.
6. Inability to follow the study protocol for treatment or follow up as scheduled.

Where it's running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Xiaoping Chen — Tongji Hospital
• Study coordinator: WanGuang Zhang
• Email: wgzhang@tjh.tjmu.edu.cn
• Phone: +8613886195965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.