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.
Before treatment, histologically or cytologically or clinically diagnosed as hepatocellular carcinoma (HCC) and the clinical stage belongs to BCLC stage A/B HCC that exceeds the Milan criteria.
Child-pugh liver function grading: Grade A or B
Did not received any type of other first-line drugs such as Sorafenib or Lenvatinib.
According to RECIST 1.1 standard and mRECIST standard, patients have at least one measurable lesion (CT scan long diameter ≥10mm and the lesion has not received radiotherapy, freezing or other local treatments)；
Have received immunotherapeutic drugs or interferon in the past.
Allergic to the drugs in the treatment ;
Female subjects with pregnancy or on feeding.
Have received other immunotherapy drugs (targeting PD1/PDL1).
Single group
mFOLFOX7 combined with Camrelizumab and apatinib
DrugmFOLFOX7(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.
Major 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.
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
pathologic complete response (pCR) rate
pCR is the proportion of surgical specimens with no tumor lesion or only carcinoma in situ.
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.
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.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
