HCC, Recurrence
Conditions
Brief summary
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.
Detailed 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.
Interventions
Adjuvant PD-1 group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles. Adjuvant PD-1 plus Lenvatinib group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV 21 days for 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months.
Sponsors
Chen Xiaoping
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease -free survival | 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 | Disease-free survival was defined as defined as the time from enrollment to diagnosis of recurrence or death from any cause. |
Countries
China
Outcome results
None listed