Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215651
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-01-10
Brief Title:
Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Phase II Single-arm Multicenter Prospective Study of Cadonilimab and Lenvatinib for Conversion Therapy in Unresectable Hepatocellular Carcinoma
Status:
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:
This study is a single-arm open-label exploratory clinical trial designed to assess the effectiveness and safety of the combination therapy of Cadonilimab and Lenvatinib for conversion treatment in unresectable hepatocellular carcinoma Eligible patients meeting the inclusion criteria and providing informed consent will undergo 3-4 cycles of Cadonilimab and Lenvatinib conversion therapy A single imaging assessment will be conducted and successfully converted patients will proceed to surgical treatment with pathological evaluation of intraoperative specimens Post-surgery patients will choose an appropriate adjuvant treatment based on prior treatment benefits disease baseline and personal preferences
Patients who do not successfully convert and experience disease progression will exit the study for alternative treatment Those who do not successfully convert but do not exhibit disease progression will continue conversion treatment with Cadonilimab and LenvatinibTACEHAIC with tumor imaging assessments every 3 cycles Successfully converted patients will undergo surgery followed by the selection of an appropriate adjuvant treatment based on prior treatment benefits disease baseline and personal preferences
Patients who do not successfully convert and experience disease progression will exit the study for alternative treatment Those who do not successfully convert but do not exhibit disease progression will continue conversion treatment with Cadonilimab and LenvatinibTACEHAIC until disease progression or intolerable toxicity occurs with a maximum treatment duration of 2 years Efficacy assessment will use mRECIST and RECIST v11 criteria and safety evaluation will follow CTCAE 50 standards Adverse events will be recorded throughout the study with a period extending to 60 days after treatment completion for serious adverse events or those related to Enfortumab Vedotin and in some cases extended to 90 days post-treatment
Patients who do not successfully convert and experience disease progression will exit the study for alternative treatment Those who do not successfully convert but do not exhibit disease progression will continue conversion treatment with Cadonilimab and LenvatinibTACEHAIC with tumor imaging assessments every 3 cycles Successfully converted patients will undergo surgery followed by the selection of an appropriate adjuvant treatment based on prior treatment benefits disease baseline and personal preferences
Patients who do not successfully convert and experience disease progression will exit the study for alternative treatment Those who do not successfully convert but do not exhibit disease progression will continue conversion treatment with Cadonilimab and LenvatinibTACEHAIC until disease progression or intolerable toxicity occurs with a maximum treatment duration of 2 years Efficacy assessment will use mRECIST and RECIST v11 criteria and safety evaluation will follow CTCAE 50 standards Adverse events will be recorded throughout the study with a period extending to 60 days after treatment completion for serious adverse events or those related to Enfortumab Vedotin and in some cases extended to 90 days post-treatment
Detailed Description:
None
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