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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. How to improve the prognosis of this group of patients is an urgent issue to be addressed.
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 are no published studies on how to improve prognosis for this population. One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis. However, PD-1 monoclonal antibody in combination with PD-1 monoclonal antibody effectively reduced postoperative recurrence and improved prognosis in VETC-positive patients. Based on our previous retrospective data, this multicenter prospective cohort study was designed to further validate and explore effective therapeutics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined adjuvant therapy group | Experimental | Patients in the combined adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection. |
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| Monotherapy group | Active Comparator | Patients in the monotherapy group received PD-1 monotherapy after liver resection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 monoclonal antibody and lenvatinib | Drug | Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | OS defined as time to death from any cause after surgery. | From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WanGuang Zhang | Contact | +8613886195965 | wgzhang@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Chen | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China | Recruiting | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
| C000711728 | spartalizumab |
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| PD-1 monoclonal antibody | Drug | Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles. |
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