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

Wan-Guang Zhang

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Sintilimab; Drug: Lenvatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT07077798

CHALLENGE-02

Details and patient eligibility

About

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.

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 One of our unpublished retrospective studies found that treatment with PD-1 monoclonal antibodies does not effectively improve the prognosis for VETC-positive patients.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

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Adjuvant group

Experimental group

Description:

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

Treatment:

Drug: Lenvatinib

Drug: Sintilimab

Control group

No Intervention group

Description:

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