Hepatocellular carcinoma
Conditions
Interventions
Grouping based on the medication of subjects:Carrilizumab in combination with Apatinib
Carrilizumab in combination with other targeted agents.:None
Sponsors
The First Affiliated Hospital of University of science and technology of China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. According to the Guidelines for the Diagnosis and Treatment of primary liver Cancer (2022 ), Grade I experts recommend carrilizumab and Apatinib for the first-line or second-line treatment of patients with unresectable or metastatic hepatocellular carcinoma, and the study population meets the guidelines for the diagnosis and treatment of the drug, guidelines or medical insurance indications, and does not use drugs beyond the indications for diagnosis and treatment, specifically: Patients with locally advanced/recurrent or metastatic hepatocellular carcinoma that is not resectable by histopathological and/or cytological examination; 2. Age =18 years old, male or female; 3.CNLC stage IIb-IIIb or BCLC stage B/C; 4. Have at least one measurable lesion (RECIST 1.1); 5.Child-Pugh: Grade A~B (= 9 points); 6.ECOG PS: 0~2 points; 7. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular carcinoma-cholangiocarcinoma (cHCC-CCA); 2. Proven allergy to the test drug and/or its excipients; 3. The subject has an immune deficiency disease or history, or has a history of organ transplantation; 4. A history of malignancies other than HCC within 5 years prior to the first dose, except malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 5. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients, coagulation mechanism disorders, thrombocytopenia, etc.; Currently receiving full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (allowing prophylactic use of low-dose aspirin, etc.) 6. Pregnant or lactating women; 7.Patients who, as determined by the investigator, have a concomitant medical condition that seriously endangers subjects' safety or interferes with subjects' completion of the study, or who have other factors that the investigator deems unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Serious adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;Quality of life impact;OS;PFS;ORR;DCR;TTF; | — |
Countries
China
Contacts
Public ContactLiu Lianxin
The First Affiliated Hospital of University of science and technology of China
Outcome results
None listed