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Trial Title:
A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib
NCT ID:
NCT06280105
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
cadonilimab (anti PD-1/CTLA-4 bispecific antibody)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab+regorafenib
Description:
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
Arm group label:
cadonilimab+regorafenib
Summary:
To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients
with hepatocellular carcinoma who failed camrelizumab plus apatinib.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mengchao Hepatobiliary Hospital, Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Start date:
March 31, 2024
Completion date:
March 31, 2027
Lead sponsor:
Agency:
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Agency class:
Other
Source:
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06280105
