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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280105
• Other study ID #: 2023_148_01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 31, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2024
• Source: Meng Chao Hepatobiliary Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Country	Name	City	State
China	Mengchao Hepatobiliary Hospital, Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Meng Chao Hepatobiliary Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Overall survival(OS)	Defined as the time from the first dose to the death from any cause.	Up to three years
Secondary	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
Secondary	Occurence of AE and SAE	Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)	Up to two years