Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy
Conditions
Brief summary
To evaluate the efficacy and safety of Cadonilimab Injection in combination with Regorafenib in the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy .
Detailed description
An open, single-arm, single-centre clinical study evaluating Cadonilimab Injection in combination with Regorafenib for the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy.
Interventions
Cadonilimab Injection, 6mg/kg, intravenous drip ,q2w,
DRUGRegorafenib
Regorafenib 80mg, po, orally once daily
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. written informed consent signed prior to enrolment. 2. age \> 18 years, both sexes 3. patients with histologically or pathologically confirmed intermediate to advanced hepatocellular carcinoma. 4. intermediate to advanced HCC previously treated with anti-PD-1/PD-L1 combined with anti-vascular targeting agents for HCC, with disease progression. 5. Child-Pugh A or B. 6. with measurable lesions (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria). 7. ECOG PS score: 0 to 1. 8. expected survival of \>12 weeks. 9. function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors within 14 days). 1\) Blood count. Neutrophils ≥ 1.5 x 109/L Platelet count ≥ 60×109/L haemoglobin ≥ 90 g/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) Glutamic aminotransferase (AST) or glutamic aminotransferase (ALT) levels ≤ 10 times the upper limit of normal (ULN); urine protein \< 2+; if urine protein ≥ 2+, 24-hour urine protein quantification must show ≤ 1 g of protein. 10\. normal coagulation function, no active bleeding or thrombotic disease 1. International normalised ratio INR ≤ 1.5 x ULN. 2. partial thromboplastin time APTT ≤ 1.5 x ULN. 3. prothrombin time PT ≤ 1.5 x ULN. 11. Female patients who are non-surgically sterilised or of childbearing age are required to use a medically approved contraceptive (e.g. IUD, pill or condom) during and for 3 months after the end of the study treatment period; female patients of childbearing age who are non-surgically sterilised must have a negative serum or urine HCG test within 7 days prior to study entry; and must be non-lactating; male patients who are non-surgically sterilised or of childbearing age Patients, need to agree to use a medically approved form of contraception with their spouse during and for 3 months after the end of the study treatment period. 12\. The subject is voluntarily enrolled in the study, is compliant and cooperates with safety and survival follow-up
Exclusion criteria
：
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate ( ORR) | up to 1 years | Defined as proportion of patients who have a best response of CR or PR |
| Overall survival (OS) | up to 3 years | OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date. |
| Progress Free Survival （PFS） | up to 3 years | Defined as the time from enrollment to disease progression or death (whichever occurs first) |
| Adverse Events (AEs) | up to 3 years | Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 |
Countries
China
Outcome results
None listed