Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKI+Cardonilizumab | Experimental | TKI:Tyrosine kinase inhibitors can serve as competitive inhibitors of adenosine triphosphate (ATP) binding to tyrosine kinase, as well as analogues of tyrosine, blocking the activity of tyrosine kinase and inhibiting cell proliferation. Cardonilizumab:It can block the interaction between PD-1, CTLA-4 and their ligands PD-L1/PD-L2, B7.1/B7.2, thereby blocking the immunosuppressive response of the PD-1 and CTLA-4 signaling pathways, promoting tumor specific T cell immune activation, and inhibiting tumor cell growth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI+Cardunilimab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR 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. | 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. | 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Overall Survival (OS) |
| Measure | Description | Time Frame |
|---|---|---|
| Any adverse events related with treatment with TKI plus Cardonizumab. | Safety and tolerability of the treatment | 3 years |
Inclusion Criteria:Participants must meet all of the following inclusion criteria to be admitted to the study:
Exclusion Criteria:Participants who meet any of the following criteria will not be eligible to participate in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) | Recruiting | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Duration from the date of initial treatment with TKI plus Cardonizumab to the date of death due to any cause.
| 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. | 3 years |
| Stable Disease (SD) | Proportion of patients with stable disease status more than 4 months. | 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. | 1.5 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |