The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are: * Objective response rate (ORR) for evaluation * Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。
Have received at least one prior systemic treatment progression or intolerance for HCC. Cardonilizumab was administered every 2 weeks on the first day of each cycle for up to 24 months in the absence of investigator judgment that there is no longer a clinical continuation benefit, intolerable toxicity, initiation of a new antitumor therapy, withdrawal of informed consent, loss of follow-up, death, or other protocol requirements for treatment termination. Cardonilizumab will complete infusion within 60 minutes (± 10 minutes). Continuous monitoring of potential infusion reactions and allowing pre-treatment of hypersensitivity reactions or infusion rate adjustment according to protocol guidelines. For subjects who cannot tolerate a 60-minute infusion, the infusion time can be extended up to 120 minutes. Dose adjustment of cardonilizumab is not allowed during treatment, but delayed dosing is allowed for up to 12 weeks (since the last dosing time). If glucocorticoids are used in the treatment of irAE, In both cases where the glucocorticoid reduction process resulted in the suspension of cardonilizumab for more than 12 weeks, or in the treatment of AE that may or may not be related to cardonilizumab, and where the investigator determined that the patient would benefit from continued treatment, permission to continue treatment was required after discussion with the sponsor medical Ombudsman.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Cardonilizumab 6mg/kg, IV, Q2W + lenvatinib 8mg (body weight \< 60kg) or 12mg(body weight ≥60kg) PO, QD, / Sorafenib 400mg, PO, BID/ Regorafenib 160mg, PO, QD/ Donafenib 200mg, PO, BID。 omniscience
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)
Beijing, Beijing Municipality, China
RECRUITINGORR Full single-arm, open, multicenter prospective clinical study
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Time frame: 3 years
Progression-free Survival (PFS)
A duration from the date of initial treatment with TKI plus Cardonizumab to disease progression (defined by RECIST 1.1) or death of any cause.
Time frame: 1.5 years
Disease Control Rate (DCR)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Time frame: 3 years
Overall Survival (OS)
Duration from the date of initial treatment with TKI plus Cardonizumab to the date of death due to any cause.
Time frame: 3 years
Duration of Response (DOR)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Time frame: 3 years
Stable Disease (SD)
Proportion of patients with stable disease status more than 4 months.
Time frame: 3 years
Progression free survival rate
Portion of patients who do not experience disease progression (defined by RECIST 1.1) or death of any cause after treated with TKI plus Cardonizumab for 3 months and 6 months, respectively.
Time frame: 1.5 years
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