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

NCT07077798 | Not Yet Recruiting DMC

• 1 other identifier: CHALLENGE-02
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

HCC; VETC; Recurrence; PD-1; Lenvatinib

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  DFS defined as time to recurrence or death after surgery.

  From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes (2)

• Overall survival

  From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months

• Adverse events

  Baseline up to 60 months

Study Arms (2)

Adjuvant group

EXPERIMENTAL

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

Drug: Sintilimab; Drug: Lenvatinib

Control group

NO INTERVENTION

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

Interventions

Sintilimab DRUG

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

Adjuvant group

Lenvatinib 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.

Adjuvant group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wan-Guang Zhang: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

sintilimab; lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wanguang Zhang

CONTACT

13886195965; wgzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share