This study was designed to evaluate the effectiveness and safety of mFOLFOX7(Oxaliplatin,Calcium Levofolinate,Fluorouracil) 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.
Hepatocellular carcinoma(HCC) 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 of\<20%. Treatment objectives for advanced liver cancer. Previously, systemic therapy and transcatheter arterial chemoembolization(TACE) 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 2(HER2) positive advanced gastric cancer from 51.9% to 74.4%. 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 carcinoma.A 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 invasion(MVI) 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 lifespan.Survival 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 Milan's standard liver cancer has a significantly higher early recovery rate. There are also studies showing that liver cancer patients who exceed Milan's standards are receiving downgraded treatment of the overall survival rate and disease progression free survival rate after liver transplantation in patients who meet Milan's 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 patient's life
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
mFOLFOX7(Oxaliplatin 85mg/m2, Calcium Levofolinate 200mg/m2, Fluorouracil 400 mg/m2 D1,2400mg/m2 maintain 46 hours,) combined with Apatinib and Camrelizumab 200mg every 3 weeks. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally after meals, once a day, for continuous medication.
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGMajor pathological response (MPR) rate
MPR rate is defined as the proportion of participants with =\<10% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review.
Time frame: 6 months
Objective Response Rate(ORR) by RECIST 1.1
ORR is the proportion of patients who achieved a complete or partial response during or after treatment
Time frame: 6 months
pathologic complete response (pCR) rate
pCR is the proportion of surgical specimens with no tumor lesion or only carcinoma in situ.
Time frame: 6 months
Duration of remission(DOR) by mRECIST
DOR is the time between the first assessment of the tumor as a complete or partial response and the first assessment as tumor progression or death.
Time frame: 12 months
Disease Control Rate(DCR) by mRECIST
DCR is the proportion of all patients who have tumors that shrink or remain stable and stay that way for a certain period of time.
Time frame: 6 months
Disease-free-survival(DFS) by RECIST 1.1
DFS is the time from the beginning of radical surgery to the first recurrence of the tumor and metastasis or death of patient for any reason.
Time frame: 12 months
Progression-Free Survival (PFS) by RECIST 1.1
PFS is intended to be the time during or after treatment when there is no disease progression.
Time frame: 12 months
Overall Survival (OS) by RECIST 1.1
OS is from the point at which treatment begins or the disease is diagnosed to the time at which the patient dies.
Time frame: 24 months
Progression-Free Survival rate (PFSR) by RECIST 1.1
PFSR is the proportion of progression-free survival patients.
Time frame: 12 months
Overall Survival Rate (OSR) by RECIST 1.1
OSR is the proportion of all surviving patients.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.