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RECRUITINGPhase 2INTERVENTIONAL

A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib

A Single-arm, Multicenter, Phase II Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Progressed on Camrelizumab Combined With Apatinib

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Sign a written willing to sign a consent form form before enrollment; 2. Age \>18 years old, both sex; 3. Histological or pathological confirmed intermediate or advanced hepatocellular carcinoma, or patients with cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD); 4. Have progressed on the combination treatment of camrelizumab and apatinib for HCC 5. Child-Pugh Class A; 6. ECOG PS score: 0\~1; 7. At least 1 measurable lesion (RECIST1.1) 8. Expected survival period≥12 weeks 9. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): 1\. Blood routine: Neutrophils≥1.5×109/L Platelet count ≥75×109/L blood count (hemoglobin) at least 90g/L; 2. Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or kidney function (creatinine clearance) at least 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 1. International normalized ratio INR≤1.5×ULN; 2. Partial thromboplastin time APTT≤1.5×ULN; 3. Prothrombin time PT≤1.5×ULN; 11. Non-surgical sterilization or female patients of childbearing age 12. Subjects voluntarily join this study, have good compliance, and cooperate with safety and survival follow-up Main Who Should NOT Join This Trial: 1. Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology; 2. Have a history of hepatic encephalopathy; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Sign a written informed consent form before enrollment; 2. Age \>18 years old, both sex; 3. Histological or pathological confirmed intermediate or advanced hepatocellular carcinoma, or patients with cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD); 4. Have progressed on the combination treatment of camrelizumab and apatinib for HCC 5. Child-Pugh Class A; 6. ECOG PS score: 0\~1; 7. At least 1 measurable lesion (RECIST1.1) 8. Expected survival period≥12 weeks 9. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): 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 1. International normalized ratio INR≤1.5×ULN; 2. Partial thromboplastin time APTT≤1.5×ULN; 3. Prothrombin time PT≤1.5×ULN; 11. Non-surgical sterilization or female patients of childbearing age 12. Subjects voluntarily join this study, have good compliance, and cooperate with safety and survival follow-up Main Exclusion Criteria: 1. Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology; 2. Have a history of hepatic encephalopathy; 3. Have a history of liver transplantation; 4. There is clinically significant pericardial effusion, and there are clinical symptoms of pleural effusion that require drainage; 5. Clinically apparent ascites is defined as meeting the following criteria: ascites can be detected by physical examination during screening or ascites needs to be drained during screening; 6. Simultaneous infection with HBV and HCV (having a history of HCV infection but negative HCV RNA can be considered as not being infected with HCV); 7. Presence of central nervous system metastasis or meningeal metastasis 8. Bleeding from esophageal or gastric varices caused by portal hypertension has occurred within 6 months before the first dose 9. Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks before the first dose 10. Arterial and venous thromboembolic events occurred within 6 months before the first dose 11. Uncontrolled high blood pressure 12. Symptomatic congestive heart failure 13. Severe bleeding tendency or coagulation disorder 14. Have a history of gastrointestinal perforation and/or fistula, intestinal obstruction within 6 months before the first dose 15. Active autoimmune disease or a history of autoimmune disease 16. Patients with HIV 17. According to the investigator's judgment, patients with other serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study.

Treatments Being Tested

DRUG

Cadonilimab+regorafenib

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

Locations (1)

Mengchao Hepatobiliary Hospital, Fujian Medical University
Fuzhou, Fujian, China