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VETC is an Effective Marker for Postoperative Adjuvant Immunotherapy

C

Chen Xiaoping

Status

Completed

Conditions

HCC
Recurrence

Treatments

Drug: PD-1 monoclonal antibody and lenvatinib

Study type

Observational

Funder types

Other

Identifiers

NCT06253364
Biomarker1

Details and patient eligibility

About

Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. However, it is not clear how the surgical prognosis of VETC-positive patients can be improved.

Full description

Previous studies have identified VETC as a new metastatic pattern independent of EMT that may be associated with immunosuppression as well as poor prognosis. Multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive patients. How to improve surgical prognosis in VETC-positive patients needs to be explored. There is no consensus on postoperative adjuvant therapy for HCC. In recent years, adjuvant immunotherapy (sintilimab) and adjuvant immunotherapy combined with targeted therapy (T+A) have been shown to be effective in improving the surgical prognosis. Therefore, the investigators retrospectively collected three surgical resection cohorts, the surgical resection alone group, the postoperative adjuvant PD-1 monotherapy group, and the postoperative adjuvant PD-1 monotherapy combined with Lenvatinib group, to compare these postoperative adjuvant therapies in a subgroup of VETC patients.

Enrollment

462 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Underwent radical hepatectomy
  • No preoperative treatment
  • Pathological confirmed HCC
  • High-risk recurrent HCC
  • Not receiving any adjuvant therapy or receiving adjuvant therapy with PD-1 monotherapy or receiving adjuvant therapy with PD-1 monotherapy in combination with Lenvatinib after surgery

Exclusion criteria

  • Macrovascular invasion
  • No available wax blocks
  • No complete clinical information

Trial design

462 participants in 3 patient groups

Liver resection group
Description:
No adjuvant therapy after hepatectomy.
Adjuvant PD-1 group
Description:
Adjuvant therapy with PD-1 monoclonal antibody after hepatectomy
Treatment:
Drug: PD-1 monoclonal antibody and lenvatinib
Adjuvant PD-1 plus Lenvatinib group
Description:
Adjuvant therapy with PD-1 monoclonal antibody combined with lenvatinib after hepatectomy.
Treatment:
Drug: PD-1 monoclonal antibody and lenvatinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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