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

NCT ID: NCT07077798

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-12-31

Brief 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 One of our unpublished retrospective studies found that treatment with PD-1 monoclonal antibodies does not effectively improve the prognosis for VETC-positive patients.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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant group

Patients in the adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

Patient receives first adjuvant sintilimab 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 8 cycles

Lenvatinib

Intervention Type: DRUG

lenvatinib is initiated orally(12 mg for body weight \>= 60kg, 8 mg for body weight \< 60kg daily), 2-4 weeks postoperatively for 6 months.

Control group

The control group patients did not receive any intervention and were actively monitored after surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sintilimab

Patient receives first adjuvant sintilimab 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 8 cycles

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years;

• No previous local or systemic treatment for hepatocellular carcinoma;

• Child-Pugh liver function score ≤ 7; ④ECOG PS 0-1; ⑤BCLC stage 0-C, underwent R0 resection and confirmed by pathology as hepatocellular carcinoma; ⑥No major systemic diseases, immunodeficiency diseases, etc.; ⑦CD34 immunohistochemical staining confirms the presence of VETC in the intratumoral vascular pattern (part or all of the field of view)

Exclusion Criteria

• Pregnant or breastfeeding women;

• Recurrent HCC, distant metastasis or other systemic tumors;

• Vascular invasion involving the mesenteric vein, main portal vein, hepatic vein or inferior vena cava;

• History of gastrointestinal bleeding within the past 4 weeks;

• Active infection; ⑥Other significant clinical and laboratory abnormalities that affect safety evaluation; ⑦Inability to follow the study protocol, receive treatment or follow-up as scheduled

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wan-Guang Zhang

OTHER

Sponsor Role: lead

Responsible Party

Wan-Guang Zhang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Wanguang Zhang

Role: CONTACT

wgzhang@tjh.tjmu.edu.cn

13886195965

Other Identifiers

CHALLENGE-02

Identifier Type: -

Identifier Source: org_study_id