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To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cadonilimab+regorafenib | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab+regorafenib | Drug | cadonilimab: 6mg/kg iv D1 Q2W; regorafenib: 80mg QD oral; Eligible patients will receive cadonilimab combined with regorafenib, until disease progression or intolerable toxicity or death or withdrawal of informed consent, whichever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) per RECIST1.1 | The proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria. | Up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | PFS was defined as the time from the first dose to the time of the first documented tumor progression (assessed by RECIST1.1 criteria) or the time of death from any cause, whichever occurred first. | Up to two years |
| Overall survival(OS) |
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Inclusion Criteria:
1. Blood routine: Neutrophils≥1.5×109/L Platelet count ≥75×109/L Hemoglobin ≥ 90g/L; 2. Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 10 times the upper limit of normal (ULN); urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that the protein must be ≤ 1g; 10. Normal coagulation function, no active bleeding or thrombosis disease
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengchao Hepatobiliary Hospital, Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
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Defined as the time from the first dose to the death from any cause. |
| Up to three years |
| Duration of response (DOR) | Defined as the time from the first dose to disease progression or death in patients who achieve complete or partial response | Up to two years |
| Occurence of AE and SAE | Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0) | Up to two years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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