Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311916
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-09
Brief Title:
Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model
Sponsor:
Chen Xiaoping
Organization:
Tongji Hospital
Study Overview
Official Title:
Efficacy and Safety of Neoadjuvant HAIC Combined With Immunotherapy and Targeted Therapy in Patients With Resectable Intermediate-stage HCC Screened by a Multimodal Deep Learning Model a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Primary liver cancer is one of the most common malignant tumors in the world and more than 90 of primary liver cancers are pathologically characterized as hepatocellular carcinoma HCC The intermediate stage BCLC-B HCC is highly heterogeneous and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate
Detailed Description:
Primary liver cancer is one of the most common malignant tumors in the world and more than 90 of primary liver cancers are pathologically characterized as hepatocellular carcinoma HCC Intermediate stage BCLC-B HCC is heterogeneous and there is no uniform consensus on the treatment of this stage of the tumor in Western and Chinese countries while the European guidelines recommend liver transplantation transarterial chemoembolization TACE and systemic medication as the first line of treatment In Eastern countries such as China BCLC-B is further categorized into stages IIa and IIb and surgical resection is recommended as the first-line treatment option for stage IIa while surgical resection can also be considered for stage IIb Retrospective studies have found that surgical resection has an overall better prognosis than non-surgical treatment However the rate of postoperative recurrence is higher than that of early HCC To address this issue new tools are urgently needed to guide the selection of appropriate treatment regimens to reduce the risk of postoperative recurrence and overall survival
Our multidisciplinary team used deep learning technology to construct an artificial intelligence prediction model of neoadjuvant therapy benefit based on pre-treatment genetic testing data digital pathology slides and imaging data enhanced MRI of 536 intermediate-stage HCC patients treated with HAIC in combination with lenvatinib and PD-1 monoclonal antibody in six centers and external center data validated the models good ability to identify the beneficiary population of the combination regimen AUC 089 Accuracy 086 The aim of this study is to study the effectiveness and safety of New-adj-Net in improving the progression of intermediate-stage HCC patients during neoadjuvant therapy and postoperative recurrence by observing the benefit of the combined neoadjuvant regimen in patients who are potentially benefited from neoadjuvant therapy and direct surgery from the perspective of precision therapy
Our multidisciplinary team used deep learning technology to construct an artificial intelligence prediction model of neoadjuvant therapy benefit based on pre-treatment genetic testing data digital pathology slides and imaging data enhanced MRI of 536 intermediate-stage HCC patients treated with HAIC in combination with lenvatinib and PD-1 monoclonal antibody in six centers and external center data validated the models good ability to identify the beneficiary population of the combination regimen AUC 089 Accuracy 086 The aim of this study is to study the effectiveness and safety of New-adj-Net in improving the progression of intermediate-stage HCC patients during neoadjuvant therapy and postoperative recurrence by observing the benefit of the combined neoadjuvant regimen in patients who are potentially benefited from neoadjuvant therapy and direct surgery from the perspective of precision therapy
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