Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04521153
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-04-27
First Post:
2020-08-18
Brief Title:
Camrelizumab Combined With Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Camrelizumab Combined With Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinomaa Randomized Open-label Parallel Multicenter Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 most common primary liver cancer Hepatectomy is a curable and effective method However the recurrence rate is as high as 5070 in 5 years after surgery Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patients prognosis This study aims to evaluate the efficacy safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma The primary purpose of this study is to evaluate the rate of subjects with major pathological response and event-free survival EFS of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma CNLC Ib-IIIa The secondary research purpose is to evaluate the R0 resection rate the rate of subjects with pathological complete response overall survival and disease-free survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma The safety and tolerability is also evaluated
Detailed Description:
Hepatocellular carcinoma HCC is the most common primary liver cancer Hepatectomy is a curable and effective method However the recurrence rate is as high as 5070 in 5 years after surgery Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patients prognosis This study aims to evaluate the efficacy safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma This trial includes subjects with CNLC IbIIaIIbIIIa HCC All eligible subjects will be randomized 11 to experimental group or control group In the experimental group patients will be treated with following neoadjuvant therapy camrelizumab and apatinib 2 cycles radical surgery postoperative TACE treatment adjuvant therapy camrelizumab and apatinib 6 cycles in the control group patients will be treated with following radical surgery postoperative TACE treatment The primary purpose of this study is to evaluate the rate of subjects with major pathological response for phase 2 study and event-free survival EFS for phase 3 study of camrelizumab combined with apatinib mesylate in the perioperative period of HCC The secondary research purpose is to evaluate the R0 resection rate the rate of subjects with pathological complete response overall survival and disease-free survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable HCC The safety and tolerability is also evaluated
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