Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05062837
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2021-09-21
Brief Title:
Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC
Sponsor:
Guangxi Medical University
Organization:
Guangxi Medical University
Study Overview
Official Title:
Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-01
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 intends to prospectively enroll CNLC stage IIIb HCC cases with extrahepatic metastasis and intrahepatic lesions that are expected to be radical resected in several domestic clinical centers and observe the OS and ORR DCR DOR TTP and PFS of patients receiving hepatectomy combined with apatinib carrelli pearl treatment
Detailed Description:
Carrelizumab was approved by CFDA for second-line indication of hepatocellular carcinoma HCC in 2020 The AHELP study led to the CFDA approval of apatinib for second-line indication of HCC in 2021 RESCUE study phase II reported the efficacy and safety data of apatinib combined with carrelizumab in first-line n 70 686 of CNLC stage IIIb and second-line n 140 758 of CNLC stage IIIb in the treatment of advanced HCC ORR was 46 and 25 2-year OS was 43 and 45 median OS was 201 and 218 months PFS was 64 and 55 months and grade 3 adverse events were 786 and 767 respectively
Local progression of intrahepatic lesions of HCC is the most important and direct cause of death while extrahepatic metastases such as lung and bone metastases progress slowly and pose a much lower threat to life than intrahepatic lesions For CNLC stage IIIb HCC although liver resection is not recommended by officical guidelines for cases with resectable intrahepatic lesions a number of retrospective studies suggest that patients in the hepatectomy even palliative resection group had significantly better OS than those in the nonsurgical group with a median OS of up to 32 months in the hepatectomy group significantly higher than 192 months in atzuzumab plus bevacizumab or 201 months in apatinib plus carrelizumab Previous retrospective studies in our center also suggest that some HCC patients with extrahepatic metastasis can still benefit from hepatectomy for long-term survival Other studies suggested that the larger the preoperative diameter of HCC tumor the greater the probability of postoperative lung metastasis The more advanced the intrahepatic tumor or the larger the tumor load the more likely the extrahepatic metastasis Therefore hepatectomy combined with targeted drugs ICI may be the best treatment for HCC with extrahepatic metastasis and radical resection of intrahepatic tumor
Local progression of intrahepatic lesions of HCC is the most important and direct cause of death while extrahepatic metastases such as lung and bone metastases progress slowly and pose a much lower threat to life than intrahepatic lesions For CNLC stage IIIb HCC although liver resection is not recommended by officical guidelines for cases with resectable intrahepatic lesions a number of retrospective studies suggest that patients in the hepatectomy even palliative resection group had significantly better OS than those in the nonsurgical group with a median OS of up to 32 months in the hepatectomy group significantly higher than 192 months in atzuzumab plus bevacizumab or 201 months in apatinib plus carrelizumab Previous retrospective studies in our center also suggest that some HCC patients with extrahepatic metastasis can still benefit from hepatectomy for long-term survival Other studies suggested that the larger the preoperative diameter of HCC tumor the greater the probability of postoperative lung metastasis The more advanced the intrahepatic tumor or the larger the tumor load the more likely the extrahepatic metastasis Therefore hepatectomy combined with targeted drugs ICI may be the best treatment for HCC with extrahepatic metastasis and radical resection of intrahepatic tumor
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