NCT07077798

Adjuvant Sintilimab Plus Lenvatinib for HCC Characterized With VETC Following Liver Resection

Adjuvant Sintilimab Plus Lenvatinib for HCC Characterized With VETC Following Liver Resection: A Multicenter Prospective Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Wan-Guang Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Vessels that encapsulate tumor clusters (VETC) are a novel invasive metastatic factor in hepatocellular carcinoma (HCC), operating independently of the epithelial-mesenchyme transition (EMT). The presence of VETC is associated with a higher rate of postoperative recurrence in HCC patients, indicating a more aggressive biological behavior.Improving the prognosis for VETC-positive patients is a critical issue in clinical oncology.

Detailed description

Previous studies have established that VETC is a novel mode of metastasis, independent of EMT, and may be associated with immune suppression and poor prognosis. Numerous retrospective studies have found that patients with VETC positivity have higher rates of postoperative recurrence and distant metastasis. How to improve the surgical prognosis for VETC-positive patients remains to be explored. Currently, there are no published studies on how to improve the prognosis for this group of individuals. One of our unpublished retrospective studies found that treatment with PD-1 monoclonal antibodies does not effectively improve the prognosis for VETC-positive patients. However, the combination of PD-1 monoclonal antibodies with lenvatinib can effectively reduce postoperative recurrence and improve prognosis in VETC-positive patients. Therefore, we have designed this multicenter, randomized controlled trial to explore the efficacy and safety of lenvatinib in combination with sintilimab in VETC-positive HCC.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Sintilimab	Patient receives first adjuvant sintilimab 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 8 cycles
DRUG	Lenvatinib	lenvatinib is initiated orally(12 mg for body weight \>= 60kg, 8 mg for body weight \< 60kg daily), 2-4 weeks postoperatively for 6 months.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-31
• Completion: 2027-12-31
• First posted: 2025-07-22
• Last updated: 2025-07-22