Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354387
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-18
Brief Title:
Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
A Pilot Study of Alectinib Alecensa in Combination With Nivolumab Opdivo in the Treatment of Recurrent or Refractory Hepatocellular Carcinoma Patients Guided With Serum Level of RNase1 and Tumor Expression of PD-L1
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Hepatocellular carcinoma HCC is the fourth most common cause of cancer-related death and the second most deadly malignancy in Taiwan Despite decades intensive studies surgery and local-regional chemo-embolization radio-frequency ablation or radiation therapy remain the mainstay of HCC treatments
Detailed Description:
For HCC that are not resectable and not amenable to loco-regional therapies the tyrosine kinase inhibitors TKIs sorafenib and its derivative regorafenib lenvatinib and caboxantinib are of the standard systemic therapy However on average only marginal improvement of overall survival has been achieved with significant variation in response to TKI among patients Effective predictive biomarkers to stratify patients for effective treatments have yet to be discovered
In recent researches the investigators have found RNase1 was highly expressed in nivolumab non-response HCC patients and human ribonuclease1 RNase1 secreted by tumor cells was positive correlated with PD-L1 level in HCC patients Notably the investigators also found RNase1 regulates macrophage polarization and promotes immunosuppression in immunotherapy by activating ALK signaling in macrophage the investigators showed that RNase1-overexpressing tumors were sensitive to ALK inhibitor and anti-PD-1 combinational therapy in HCC orthotopic mouse model
Thus the investigators hypothesize that RNase1 is a potential biomarker for ALK inhibitor and anti-PD-1 combinational therapy in HCC HCC patients who fit into the criteria would be benefit from ALK inhibitor alectinib and anti-PD-1 agent nivolumab combinational therapy To test the role of circulatory RNase1 as a predictive biomarker for responsiveness to ALK inhibitor alectinib and anti-PD-1 agent nivolumab combinational therapy in Recurrent or Refractory HCC patients the investigators propose the following pilot clinical studies in patients of HCC who failed the standard TKIs treatment Total 8 evaluable subjects will be included Participants will receive Alectinib Alecensa which has been approved for the treatment of ALK NSCLCROS-1 NSCLC and Nivolumab Opdivo has been approved for the treatment of several cancer types Both of Alectinib and Nivolumab have also been under the reimbursement policy of Taiwan NHIA
In recent researches the investigators have found RNase1 was highly expressed in nivolumab non-response HCC patients and human ribonuclease1 RNase1 secreted by tumor cells was positive correlated with PD-L1 level in HCC patients Notably the investigators also found RNase1 regulates macrophage polarization and promotes immunosuppression in immunotherapy by activating ALK signaling in macrophage the investigators showed that RNase1-overexpressing tumors were sensitive to ALK inhibitor and anti-PD-1 combinational therapy in HCC orthotopic mouse model
Thus the investigators hypothesize that RNase1 is a potential biomarker for ALK inhibitor and anti-PD-1 combinational therapy in HCC HCC patients who fit into the criteria would be benefit from ALK inhibitor alectinib and anti-PD-1 agent nivolumab combinational therapy To test the role of circulatory RNase1 as a predictive biomarker for responsiveness to ALK inhibitor alectinib and anti-PD-1 agent nivolumab combinational therapy in Recurrent or Refractory HCC patients the investigators propose the following pilot clinical studies in patients of HCC who failed the standard TKIs treatment Total 8 evaluable subjects will be included Participants will receive Alectinib Alecensa which has been approved for the treatment of ALK NSCLCROS-1 NSCLC and Nivolumab Opdivo has been approved for the treatment of several cancer types Both of Alectinib and Nivolumab have also been under the reimbursement policy of Taiwan NHIA
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?:
False
Is an FDA AA801 Violation?:
None