Hepatocellular Carcinoma
Conditions
Interventions
Group A:D-TACE combined with continuous hepatic arterial infusion chemotherapy and first-line systemic therapy
Group B:Treatment with D-TACE combined with molecular targeted drugs and immune checkpoint inhibitors
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily enroll in the group and sign a written informed consent form; 2. Aged 18 - 80 years old (including 80 years old), regardless of gender; 3. Patients with hepatocellular carcinoma diagnosed clinically according to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)" or confirmed by histology/cytology, with CNLC stage: II - III; 4. Patients with unresectable hepatocellular carcinoma and a main lesion = 10 cm; 5. Have not received systematic treatment; 6. The end time of the last TACE, radiotherapy, and ablation treatment is > 4 weeks; 7. For patients who have previously undergone liver resection, it should be R0 resection, and tumor recurrence should be more than 24 months after the operation; 8. Have at least one assessable lesion (according to RECIST 1.1 criteria); 9. The expected survival time is >= 3 months; 10. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0 - 1; 11. The Child - Pugh score is = 90 g/L; b. Absolute neutrophil count (ANC) >= 1.5×10?/L; c. Platelet count >= 75×10?/L; Blood biochemical examination: d. Albumin >= 28 g/L; e. Total bilirubin <= 2× the upper limit of normal (ULN); f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 5×ULN; g. Alkaline phosphatase (ALP) <= 5×ULN; h. Creatinine <= 1.5×ULN; Coagulation function: i. International normalized ratio (INR) or prothrombin time (PT) <= 1.5×ULN; Activated partial thromboplastin time (APTT) <= 1.5×ULN.
Exclusion criteria
Exclusion criteria: 1. Previously histologically/cytologically confirmed components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.; 2. A history of malignant tumors other than hepatocellular carcinoma, unless the following criteria are met: The patient has received possible curative treatment and there is no evidence of the disease within 5 years; Skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinomas in situ that have been successfully resected; 3. Diffuse tumor lesions; 4. A history of hepatic encephalopathy, hepatorenal syndrome, or a history of liver transplantation; 5. Pleural effusion, ascites, or pericardial effusion that requires drainage due to clinical symptoms; 6. Central nervous system metastasis; 7. Suffering from diseases that affect the absorption, distribution, metabolism, or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); 8. Previous or concurrent medications/treatments: Previous treatment with targeted therapies against signaling pathways such as anti - VEGF and/or VEGFR, RAF, MEK (e.g., sorafenib, lenvatinib, regorafenib) or immunomodulators such as anti - PD - 1, anti - PD - L1, anti - CTLA - 4; Previous hepatic arterial infusion chemotherapy; Safety: 9. Active bleeding or abnormal coagulation function, with a bleeding tendency or currently receiving thrombolytic, anticoagulant, or anti - platelet therapy; 10. Other significant clinical and laboratory abnormalities that the investigator believes affect the safety evaluation, such as uncontrolled diabetes, chronic kidney disease, grade II or higher peripheral neuropathy (CTCAE V5.0), abnormal thyroid function, etc.; 11. Active infections requiring treatment; 12. Active hepatitis B (HBsAg positive and abnormal liver function): If the HBV - DNA is =104 copies/ml within 14 days before treatment, antiviral treatment should be carried out first until it drops below 104 copies/ml before entering the study, and antiviral treatment should be continued while monitoring liver function and serum HBV - DNA levels; 13. Active hepatitis C (HCV - RNA =10³ copies/ml and abnormal liver function [ALT or AST > 3×ULN accompanied by TBIL > 2×ULN or clinical jaundice]); 14. Not recovered from surgery, such as having unhealed incisions or severe postoperative complications; 15. Pregnant or lactating women, and male or female patients of child - bearing potential who are unwilling or unable to take effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;progression-free survival time;Overall survival; | — |
Countries
China
Contacts
Public ContactZhuting Fang, Shiguang Chen
Fujian Cancer Hospital
Outcome results
None listed