Clinical trial NCT06280105: A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: cadonilimab (anti PD-1/CTLA-4 bispecific antibody)
Lead sponsor: Meng Chao Hepatobiliary Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

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.

Primary outcomes:
measure: objective response rate (ORR) per RECIST1.1
timeFrame: Up to two years
Secondary outcomes:
measure: Progression-free survival（PFS）
timeFrame: Up to two years
measure: Overall survival（OS）
timeFrame: Up to three years
measure: Duration of response (DOR)
timeFrame: Up to two years
measure: Occurence of AE and SAE
timeFrame: Up to two years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital, Fujian Medical University
state: Fujian
Study officials:
References: