This study used (cTACE or DEB-TACE + FOLFOX scheme HAIC) combined with PD-1 antibody camrelizumab and apatinib mesylas in the treatment of patients with advanced liver cancer, to evaluate the effectiveness and safety of the combined treatment for clinical liver cancer treatment.It will provide new evidence-based medical evidence.This study is a prospective, open, single center, exploratory clinical study and the sample size is 56.Main research purpose:To evaluate the effectiveness of cTACE or DEB-TACE + FOLFOX regimen HAIC combined with camrelizumab and apatinib mesylas in the treatment of advanced hepatocellular carcinoma.Secondary research purpose:To evaluate the safety of cTACE or DEB-TACE + FOLFOX regimen HAIC combined with camrelizumab and apatinib mesylas in the treatment of advanced hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Camrelizumab for injection is used to treat patients with relapsed or refractory classic Hodgkin lymphoma who have undergone at least second-line chemotherapy. Approved by the Drug Administration (NMPA) on March 4, 2020, for the treatment of patients with advanced hepatocellular carcinoma who have previously received sorafenib therapy and/or oxaliplatin-containing chemotherapy.Apatinib Mesylas is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant tumors by inhibiting VEGFR to play an anti-angiogenic effect. It has been approved by the China Food and Drug Administration (CFDA) in November 2014. It is used as a monotherapy for advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma that has progressed or relapsed after receiving two kinds of systemic chemotherapy. Apatinib Mesylas can effectively inhibit VEGFR2 at very low concentrations, and higher concentrations can also inhibit PDGFR, c-Kit and c-Src and other kinases.
PFS
PFS refers to the length of time from the beginning of treatment to disease progression or death for any reason.
Time frame: Up to 2 years.
ORR
The objective response rate (ORR) refers to the proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit.
Time frame: Up to 2 years.
DCR
Disease control rate (DCR) refers to the proportion of patients whose tumors shrink or stabilize and remain for a certain period of time, including cases with complete response (CR), partial response (PR), and stable (SD).
Time frame: Up to 2 years.
OS
Overall survival (OS) refers to the time from enrollment to death due to any cause.
Time frame: Up to 2 years.
Incidence of AE and SAE
All adverse events in all subjects in the study.
Time frame: Up to 2 years.
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