Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461936
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Intra-Tumoral Vascular Growth Patterns is a Robust Indicator of Adjuvant Therapy Following Liver Resection in HCC
Sponsor:
Chen Xiaoping
Organization:
Tongji Hospital
Study Overview
Official Title:
Intra-Tumoral Vascular Growth Patterns is a Robust Indicator of Adjuvant PD-1 Inhibitors Following Liver Resection in Hepatocellular Carcinoma A Multicenter Cohort and Multiomics Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
Hepatocellular carcinoma HCC is a common malignancy worldwide with the number of new cases and deaths increasing yearly Curative surgery continues to be the preferred treatment for early-stage HCC However some early-stage HCC often experience early recurrence after surgery and one of the most common risk factors is microvascular invasion MVI Nevertheless the overall prognosis of some MVI-negative patients is also not satisfactory Whether there are other hidden robust risk factors for recurrence is of intense interest to clinical scientists
In contrast to the classic capillary pattern cobweb-like pattern of vascular is present in renal cell carcinoma thyroid follicular carcinoma and HCC Specifically this particular vascular pattern is a continuous lining of sinusoid-like vessels that isolate and encapsulate individual tumor clusters and Fang et al named it vessels that encapsulate tumor clusters VETC CD34 or CD31 immunohistochemical staining of tumor tissue can easily identify the vascular pattern of VETC which can exist at any stage of HCC accounting for about 40-506 VETC could directly invade adjacent vascular and migrate as tumor clusters instead of epithelial-mesenchymal transition pathway which may well explain why VETC-positive HCC is closely associated with higher postoperative recurrence rate and poor prognosis Due to the high proportion of VETC vascular patterns and poor prognosis it is necessary to adopt effective adjuvant treatment Zhuan et al found that unresectable VETCHCC could benefit from treatment with sorafenib in a subsequent study Similarly another study found that FGF 2 and FGFR 3-4 rather than VEGF-A or VEGFR 1-3 were high expression in VETC HCC which raise the possibility that lenvatinib is a potentially effective treatment modality Recently a multicenter randomized controlled trial of postoperative adjuvant Sintilimab reported encouraging positive results suggesting the possibility of its application in VETC-positive patients Whether the combination of lenvatinib and Sintilimab can further improve the prognosis is also worth exploring
To address these clinical challenges the investigators conducted a multicenter study involving three surgical cohorts with postoperative active surveillance cohortAC adjuvant Sintilimab cohortAS and adjuvant Sintilimab plus Lenvatinib cohortASL The cases in the AS cohort were mainly from a previous prospective cohort study initiated by the investigators center and a later cohort expansion NCT05307926 Moreover multi-omics sequencing analysis aims to further explore the molecular biological characteristics between VETC positive and negative HCC
In contrast to the classic capillary pattern cobweb-like pattern of vascular is present in renal cell carcinoma thyroid follicular carcinoma and HCC Specifically this particular vascular pattern is a continuous lining of sinusoid-like vessels that isolate and encapsulate individual tumor clusters and Fang et al named it vessels that encapsulate tumor clusters VETC CD34 or CD31 immunohistochemical staining of tumor tissue can easily identify the vascular pattern of VETC which can exist at any stage of HCC accounting for about 40-506 VETC could directly invade adjacent vascular and migrate as tumor clusters instead of epithelial-mesenchymal transition pathway which may well explain why VETC-positive HCC is closely associated with higher postoperative recurrence rate and poor prognosis Due to the high proportion of VETC vascular patterns and poor prognosis it is necessary to adopt effective adjuvant treatment Zhuan et al found that unresectable VETCHCC could benefit from treatment with sorafenib in a subsequent study Similarly another study found that FGF 2 and FGFR 3-4 rather than VEGF-A or VEGFR 1-3 were high expression in VETC HCC which raise the possibility that lenvatinib is a potentially effective treatment modality Recently a multicenter randomized controlled trial of postoperative adjuvant Sintilimab reported encouraging positive results suggesting the possibility of its application in VETC-positive patients Whether the combination of lenvatinib and Sintilimab can further improve the prognosis is also worth exploring
To address these clinical challenges the investigators conducted a multicenter study involving three surgical cohorts with postoperative active surveillance cohortAC adjuvant Sintilimab cohortAS and adjuvant Sintilimab plus Lenvatinib cohortASL The cases in the AS cohort were mainly from a previous prospective cohort study initiated by the investigators center and a later cohort expansion NCT05307926 Moreover multi-omics sequencing analysis aims to further explore the molecular biological characteristics between VETC positive and negative HCC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None