Hepatocellular carcinoma
Conditions
Interventions
Monotherapy treatment group:None
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Typical imaging manifestations of hepatocellular carcinoma, elevated AFP or pathological diagnosis of hepatocellular carcinoma; 2. At least two imaging evaluations based on contrast-enhanced CT or contrast-enhanced MR before receiving combination therapy or monotherapy, and the target lesions can be measured according to the RECIST1.1/mRECIST criteria; 3. Have at least one evaluation of hematological tumor indicators, liver function and blood routine before receiving combination therapy or monotherapy; 4. Have not received immunotherapy including PD-1 monoclonal antibody in the past; 5. At least one imaging evaluation based on contrast-enhanced CT or contrast-enhanced MR after receiving combination therapy or monotherapy, the imaging evaluation needs to be completed within 2 months after receiving immunotherapy, and the target lesions can be measured according to RECIST1.1 criteria. Combination therapy group: The first dose of PD1 monoclonal antibody immunotherapy should be given within 1 month after the end of ablation; During the imaging evaluation before and after treatment, no other treatment other than TKI drugs was received; Anti-angiogenic antineoplastic drugs can be used before and after treatment; TKI medication consistency during pre- and post-treatment imaging evaluation; The interval between the last local treatment and the combination treatment is more than 3 months; Monotherapy group: During the imaging evaluation before and after treatment, no other treatment other than TKI drugs was received. Anti-angiogenic antineoplastic drugs may be used before and after treatment. The interval between the last local treatment and the combination treatment was more than 3 months. Anti-angiogenic antineoplastic drugs and PD1 monoclonal antibodies were consistent during pre- and post-treatment imaging evaluation.
Exclusion criteria
Exclusion criteria: Combined with severe functional impairment of other vital organs such as heart, brain, lung, kidney, etc., combined with severe infection or other serious concomitant diseases (> grade 2 CTCAE Version 4.03 adverse events); The patient is using immunosuppressants, or systemic hormone therapy to achieve immunosuppressive purposes (dose> 10mg/day prednisone or other effective hormones) during the course of the disease, and continues to use them within 2 weeks before immunotherapy; Known history of hepatic encephalopathy; Those with a history of organ transplantation; As judged by the investigator, the patient has other serious diseases (including mental illnesses) that may affect the results of the study, such as drug abuse and other serious illnesses (including mental illnesses); Previous immunotherapy such as DIK, CTLA-4 monoclonal antibody therapy, etc.; Change of antineoplastic drugs during pre- and post-treatment imaging evaluation. Note: Incomplete ablation is defined as the presence of tumor active lesions within 1cm of the edge of the ablation lesion on enhanced CT/MR review after ablation, or the ablation and inactivation of all tumor active lesions judged by follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactZuo Mengxuan
Sun Yat-sen University Cancer Center
Outcome results
None listed