hepatocellular carcinoma
Conditions
Interventions
one-arm:Lenvatinib+camrelizumab
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged from 18 to 75 years who are pathologically diagnosed with HCC (excluding cholangiocarcinoma, fiberboard layer, sarcomatoid and mixed cholangiocarcinoma, etc.) or who are clinically diagnosed with HCC according to the 2019 edition of Chinese Primary Liver Cancer Diagnosis and Treatment Code; 2) Patients with advanced HCC who cannot be resected or have recurrence/metastasis after operation; 3) ECOG score 0-1, Child-Pugh liver function rating A/B; 4) BCLC stage is B-C stage; 5) There is >= 1 measurable lesion (according to RECIST 1.1 standard); 6) Patients who have not received systemic treatment for liver cancer in the past, but who have progressed or lasted for more than 28 days after receiving sorafenib or lenvatinib treatment; 7) In addition to meeting the above conditions, all subjects are required to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) The patient has obvious bile duct invasion (clinically classified as cholestatic liver cancer, and the initial manifestation of the patient is obstructive jaundice and bile duct infiltration caused by the formation/compression/diffusion of tumor thrombus); 2) Have had blood enhancement therapy (including blood transfusion/blood products or drugs for stimulating blood cell growth, such as granulocyte colony stimulating factor, etc.) within 28 days before taking the study drug for the first time; 3) The neutrophil count (ANC), HB 2.3, prothrombin time (PT) prolonged > 6 seconds; 5) Renal function index: serum creatinine (CRE) > 1.5 times the upper limit of normal value; 6) Complicated with immune system diseases or severe cardiovascular and cerebrovascular diseases or other malignant tumors; 7) Participated in other clinical trials 30 days before screening; 8) The researcher thinks it is unsuitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactHuang Zhiyong
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed