Hepatocellular carcinoma
Conditions
Interventions
single group:No
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily accept the treatment of Donafenib combined with TACE or HAIC, and sign a written informed consent; 2. 18~70 years old, male or female; 3. Hepatocellular carcinoma confirmed by pathological examination or conforming to clinical diagnostic criteria; 4. Have not received surgery or chemotherapy, immunotherapy, targeted therapy and other systemic treatments before enrollment; 5. The CNLC stage is Ib-IIIb; 6. According to the modified solid tumor response evaluation criteria (mRECIST criteria), there is at least one evaluable target lesion, and the size of the lesion is = 12 weeks; 10. Can cooperate to observe adverse events and curative effects; 11. The function of major organs is normal, that is, the following criteria are met: (1) Routine blood examination (no blood transfusion and no G-CSF use within 14 days before screening): hemoglobin >= 90 g/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet count >= 50 x 10^9/L; (2) Blood biochemical examination (albumin was not used within 14 days before screening): albumin >= 28 g/L; total bilirubin <= 2 x upper limit of normal (ULN); aspartate aminotransferase (AST), Alanine aminotransferase (ALT)<= 5 x ULN; Alkaline phosphatase (ALP)<= 5 x ULN; Creatinine <= 1.5 x ULN; (3) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN; activated partial thromboplastin time (APTT) <= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed histologically/cytologically containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. The patients under observation have suffered from other malignant tumors in the past or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 3. Participate in other drug clinical trials/device clinical trials within 3 months before enrollment; 4. The presence of pericardial effusion, uncontrolled pleural effusion or clinically severe ascites; 5. Serious infection in active stage or poorly controlled clinically; 6. Have a history of mental illness; 7. Received any local treatment other than TACE (including but not limited to surgery, radiotherapy, hepatic artery embolization, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) within 4 weeks before participating in the study; 8. Having experienced thrombosis or thromboembolic events in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.; 9. Hemorrhagic events of esophageal or gastric varices caused by portal hypertension within the past 6 months, or any life-threatening bleeding events within 3 months; 10. Other significant clinical and laboratory abnormalities that the investigators consider to affect the safety evaluation, such as: uncontrolled diabetes mellitus, chronic kidney disease, peripheral neuropathy of grade II or above (CTCAE V5.0), abnormal thyroid function, etc.; 11. Patients with congenital or acquired immunodeficiency (such as HIV infection), or patients with acute or chronic active hepatitis B or hepatitis C infection, HBV DNA > 2000IU/ml; HCV RNA > 10^3 copies/ml; 12. Pregnant or breastfeeding women, as well as female or male patients with reproductive potential who are unwilling or unable to take effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;disease control rate;time to disease progression;overall survival; | — |
Countries
China
Contacts
Public ContactSong Jinlong
Shandong Cancer Hospital
Outcome results
None listed