hepatic cancer
Conditions
Interventions
Experimental group:D-TACE combined with tislelizumab injection
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Pathological examination or confirmed as HCC by clinical diagnostic criteria; 3. Have not received surgery or chemotherapy, immunotherapy, targeted therapy and other systemic treatments before enrollment; 4. BCLC stage is A, B or C, but BCLCC stage patients with portal vein tumor thrombus are not selected; 5. According to the Modified Response Evaluation Criteria for Solid Tumors (mRECIST), at least one target lesion can be evaluated; 6. Child-Pugh score= 12 weeks; 9. No autoimmune or inflammatory bowel disease.
Exclusion criteria
Exclusion criteria: 1. According to the judgment of the researcher, the patients have other factors that may lead to the forced termination of the study, for example, other serious diseases (including psychiatric diseases) require concomitant treatment, there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the patients, or the collection of data and samples; 2. Participate in other clinical trials/drug trials within 3 months before enrollment; 3. The presence of pericardial effusion, uncontrolled pleural effusion or clinically severe ascites; 4. Received any local treatment other than TACE (including but not limited to surgery, radiotherapy, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) active infection within 4 weeks before participating in the study; 5. Patients with severe abnormal liver function and abnormal coagulation function within 2 months before randomization; 6. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.) or arterial and venous thrombosis events in the past 6 months (before enrollment) ; 7. The patient has active infection or unexplained fever > 38.5 degrees during the screening period and before the first dose; 8. Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc.; 9. Patients with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal; hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value ); 10. The patient has previously or concurrently suffered from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactSong Jinlong
Outcome results
None listed