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

NCT ID: NCT06280105

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2027-03-31

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cadonilimab+regorafenib

Group Type: EXPERIMENTAL

Cadonilimab+regorafenib

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meng Chao Hepatobiliary Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yongyi Zeng

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mengchao Hepatobiliary Hospital, Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yong yi Zeng

Role: primary

lamp197311@126.com

0591-88112829

Other Identifiers

2023_148_01

Identifier Type: -

Identifier Source: org_study_id