This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (HCC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Camrelizumab at 200 mg via intravenous administration (IV), once every 2 weeks (Q2W), in combination with 250 mg of rivoceranib mesylate, oral administration, once a day (QD)
Rivoceranib mesylate (750 mg, QD, po)
Sorafenib tosylate (400 mg, twice a day (BID), po)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Stage I:Objective Response Rate(ORR)
Time frame: 2.5 years
Stage II:Overall survival (OS)
Time frame: 2.5 years
Stage I:Overall survival (OS)
Time frame: 2.5 years
Adverse Events(AEs)
Time frame: 2.5 years
Stage II:Objective Response Rate(ORR)
Time frame: 2.5 years
Disease Control Rate(DCR)
Time frame: 2.5 years
Duration of Response(DoR)
Time frame: 2.5 years
Progression-Free-Survival (PFS)
Time frame: 2.5 years
time to progression (TTP)
Time frame: 2.5 years
Pharmacokinetics (PK) Ctrough of camrelizumab
Time frame: 2.5 years
Pharmacokinetics (PK) Ctrough of Apatinib
Time frame: 2.5 years
Proportion of anti- camrelizumab antibody (ADA)
Time frame: 2.5 years
Proportion of neutralizing antibody (Nab)
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Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)
Time frame: 2.5 years