Comparing triple and dual therapies after liver surgery for liver cancer

Effectiveness of Triple Versus Dual Adjuvant Therapy in VETC-positive Population Following Liver Resection for HCC: a Prospective Multicenter Cohort Study

This study is testing if a combination of three treatments after liver surgery can help people with liver cancer do better and have fewer chances of the cancer coming back compared to just using two treatments.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: sintilimab, lenvatinib, chemotherapy, immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06311942 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of triple adjuvant therapy, which includes hepatic artery infusion chemotherapy (HAIC), PD-1 inhibitors, and lenvatinib, compared to dual therapy with PD-1 inhibitors and lenvatinib in patients with hepatocellular carcinoma (HCC) exhibiting a specific vascular pattern known as VETC. The study aims to improve surgical outcomes and reduce recurrence rates in this high-risk population. It builds on previous findings that suggest VETC-positive patients have poorer prognoses and explores novel treatment combinations to enhance recovery post-surgery.

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 HCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce recurrence rates in patients with aggressive liver cancer following surgery.

How similar studies have performed: While there have been no published studies specifically targeting VETC-positive patients, previous research indicates that combined therapies may improve outcomes in similar populations.

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; HAIC; Lenvatinib; PD-1 inhibitors