hepatocellular carcinoma
Conditions
Interventions
single-arm:regorafenib + PD-1 monoclonal antibody
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged between 18 and 75 years old and confirmed by histocytology as HCC or clinically diagnosed as HCC according to the Chinese Standards for the Diagnosis and Treatment of Primary Liver Cancer in 2019; 2) Unresectable advanced HCC patients, including HCC patients with postoperative recurrence/metastasis; 3) ECOG score 0-1 points, Child-Pugh liver function rating A/B; 4) Eligible patients have not received systemic treatment for liver cancer before, but patients who have received a targeted drug treatment progress or persistent SD are not excluded; 5) There are >=1 measurable lesions (according to RECIST 1.1 standard); 6) In addition to meeting the above conditions, all subjects are required to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1) The patient has obvious bile duct invasion (clinically classified as cholestatic liver cancer, the patient's initial manifestation is obstructive jaundice and biliary infiltration caused by tumor thrombosis/ compression/ spread); 2) Any blood enhancement treatment (including blood transfusion/blood products or application of drugs that stimulate blood cell growth, such as granulocyte colony stimulating factor, etc.) within 28 days before the first administration of the study drug; 3) Hematology examination neutrophil count (ANC)2.3, prothrombin time (PT) prolonged>6 seconds; 5) Renal function indicators: serum creatinine (CRE)> 1.5 times the upper limit of normal; 6) Combined with immune system disease or severe cardiovascular and cerebrovascular disease or other malignant tumors; 7) Participated in other clinical trials 30 days before screening; 8) The researcher believes that it is not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHuang Zhiyong
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed