Targeted therapy after surgery for liver cancer

VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: a Prospective Multicenter Cohort Study

This study is testing if a combination of two drugs can help patients with a specific type of liver cancer who are at high risk of their cancer coming back after surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06311929 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of hepatocellular carcinoma and the presence of VETC vascular pattern.

Not a fit: Patients with serious organic diseases or those who have received prior treatment for hepatocellular carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative recurrence rates in patients with VETC-positive hepatocellular carcinoma.

How similar studies have performed: While previous studies have identified VETC as a significant factor in prognosis, this specific combination therapy has not been extensively tested, making this approach novel.

Eligibility criteria

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 this trial is running

Wuhan, Hubei

• 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

Conditions HCC; Adjuvant therapy; VETC; PD-1 inhibitor; Lenvatinib