Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607107
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
mFOLFOX7 Plus Camrelizumab and Apatinib in BCLC Stage AB Hepatocellular Carcinoma Patients Beyond Milan Criteria
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Systemic ChemotherapymFOLFOX7 Combined With Camrelizumab and Apatinib in BCLC Stage AB Hepatocellular Carcinoma Patients Beyond Milan Criteria
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to evaluate the effectiveness and safety of mFOLFOX7OxaliplatinCalcium LevofolinateFluorouracil combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma
The primary outcome measure is to evaluate the primary pathological response MPR rate of the therapy for Hepatocellular Carcinoma
The secondary Outcome measures include the objective response rate ORR the duration of response DOR disease control rate DCR progression-free survival rate PFSR Time Frame 6- and 12-month overall survival rate OSR Time Frame 6- and 12-month the median progression-free survival time mPFS and median overall survival time mOS of the therapy for Hepatocellular Carcinoma
Moreover this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma
The primary outcome measure is to evaluate the primary pathological response MPR rate of the therapy for Hepatocellular Carcinoma
The secondary Outcome measures include the objective response rate ORR the duration of response DOR disease control rate DCR progression-free survival rate PFSR Time Frame 6- and 12-month overall survival rate OSR Time Frame 6- and 12-month the median progression-free survival time mPFS and median overall survival time mOS of the therapy for Hepatocellular Carcinoma
Moreover this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma
Detailed Description:
Hepatocellular carcinomaHCC is a common high-grade malignant tumor in my country with limited treatment options and poor prognosis
Early and middle stage BCLC A or B surgical resection is the main curative method for liver cancer except for a few very early stages Small liver cancer has a high short-term recurrence rate after surgery with a median survival time of about 2 years and a 5-year survival rate of20 Treatment objectives for advanced liver cancer
Previously systemic therapy and transcatheter arterial chemoembolizationTACE were mainly used for treatment while targeted therapy and immunotherapy in systemic therapy have made rapid progress in recent years
Trastuzumab and chemotherapy can increase the ORR of human epidermal growth factor receptor 2HER2 positive advanced gastric cancer from 519 to 744
Preliminary small sample studies have shown that veins the combination of mFOLFOX7 regimen with Carolizumab and Apatinib may be a potential treatment for CNLC stage III hepatocellular carcinomaA strategy that is effective safe and easy to implement with preliminary research results similar to FOLFOX-HAIC combined with targeted immunotherapy Especially for patients with concomitant main portal vein tumor thrombus showed very good results and the extremely low microvascular invasionMVI in postoperative pathology also suggests the possibility of good therapeutic value for microvascular metastasis of liver cancer
The Milan standard is an international standard used in liver transplantation and patients who meet the standard have a lower recurrence rate and a longer lifespanSurvival period specifically as follows 1 The diameter of a single tumor does not exceed 5 cm 2 The number of multiple tumors should not exceed 3 and the most Large diameter not exceeding 3cm 3 The tumor has no invasion of large hepatic vessels or distant metastasis We can also find that the Milan standard can significantly distinguish the treatment effect of liver cancer and surpassing Milans standard liver cancer has a significantly higher early recovery rate There are also studies showing that liver cancer patients who exceed Milans standards are receiving downgraded treatment of the overall survival rate and disease progression free survival rate after liver transplantation in patients who meet Milans criteria are correlated with the overall survival rate after liver transplantation nearly Therefore in our study neoadjuvant therapy targeting liver cancer with a high risk of recurrence has a high clinical value The significance and expectation of camrelizumab and apatinib combined with intravenous mFOLFOX7 chemotherapy regimen are to improve the MPR rate of liver cancer treatment and reduce patient risk
The MVI rate is increased to achieve a phase reduction effect and prolong the patients life
Early and middle stage BCLC A or B surgical resection is the main curative method for liver cancer except for a few very early stages Small liver cancer has a high short-term recurrence rate after surgery with a median survival time of about 2 years and a 5-year survival rate of20 Treatment objectives for advanced liver cancer
Previously systemic therapy and transcatheter arterial chemoembolizationTACE were mainly used for treatment while targeted therapy and immunotherapy in systemic therapy have made rapid progress in recent years
Trastuzumab and chemotherapy can increase the ORR of human epidermal growth factor receptor 2HER2 positive advanced gastric cancer from 519 to 744
Preliminary small sample studies have shown that veins the combination of mFOLFOX7 regimen with Carolizumab and Apatinib may be a potential treatment for CNLC stage III hepatocellular carcinomaA strategy that is effective safe and easy to implement with preliminary research results similar to FOLFOX-HAIC combined with targeted immunotherapy Especially for patients with concomitant main portal vein tumor thrombus showed very good results and the extremely low microvascular invasionMVI in postoperative pathology also suggests the possibility of good therapeutic value for microvascular metastasis of liver cancer
The Milan standard is an international standard used in liver transplantation and patients who meet the standard have a lower recurrence rate and a longer lifespanSurvival period specifically as follows 1 The diameter of a single tumor does not exceed 5 cm 2 The number of multiple tumors should not exceed 3 and the most Large diameter not exceeding 3cm 3 The tumor has no invasion of large hepatic vessels or distant metastasis We can also find that the Milan standard can significantly distinguish the treatment effect of liver cancer and surpassing Milans standard liver cancer has a significantly higher early recovery rate There are also studies showing that liver cancer patients who exceed Milans standards are receiving downgraded treatment of the overall survival rate and disease progression free survival rate after liver transplantation in patients who meet Milans criteria are correlated with the overall survival rate after liver transplantation nearly Therefore in our study neoadjuvant therapy targeting liver cancer with a high risk of recurrence has a high clinical value The significance and expectation of camrelizumab and apatinib combined with intravenous mFOLFOX7 chemotherapy regimen are to improve the MPR rate of liver cancer treatment and reduce patient risk
The MVI rate is increased to achieve a phase reduction effect and prolong the patients life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None