Advanced unresectable hepatocellular carcinoma
Conditions
Interventions
Study group:Innovative physical method mixed lipiodol-platinum drugs combined with immunotherapy
Control group:traditional interventional surgery
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The general condition of the patient is good, there is no history of other diseases except liver cancer, the gender is not limited, the age is 18-60 years old, and the life expectancy is =3 months; 2. Primary liver cancer that has been confirmed by histology or cytology, or meets the clinical diagnostic criteria (basis of chronic liver disease, typical imaging features, and AFP changes) in the "Code for the Diagnosis and Treatment of Primary Liver Cancer" (version 2022) promulgated by the National Health and Medical Commission. patients with hepatocellular carcinoma; 3. BCLC stage B or C, unresectable 4. There is at least one measurable lesion in the liver; 5. The primary branch of the portal vein in at least one leaf is unobstructed; 6. Those whose liver function is Child-A grade or whose liver function is Child-B grade can reach Child-A grade after liver protection, nutritional rehydration and other treatments; 7. Eastern Cooperative Oncology Group status score (ECOG PS) = 2; 8. Blood routine, biochemical, coagulation and other blood indicators are normal; 9. No history of cardiopulmonary disease in the past, normal heart and kidney function, and no toxic drugs such as cardiotoxicity and nephrotoxicity; 10. Inform the patient of the possible advantages and disadvantages before and after the operation in detail, and the patient and his family members voluntarily choose the treatment plan and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have previously received treatment for liver cancer or portal vein tumor thrombus (including: surgery, external radiotherapy, molecular targeted drugs, immunotherapy, local ablation, TAI/TACE, etc.) 2. The tumor thrombus extends into the superior mesenteric vein and/or splenic vein; 3. Combined with hepatic vein, inferior vena cava tumor thrombus or extrahepatic metastasis; 4. Combined with diagnosed malignant tumors in other parts; 5. Patients with heart, lung, kidney, brain and other important organ diseases; 6. Contraindications for combined TACE: diffuse liver cancer or tumor volume accounting for 70% or more of the whole liver, intractable massive ascites, high intrahepatic arteriovenous shunt; total bilirubin > 51umol/L and (or) albumin < 28g/L, those who fail to improve after symptomatic treatment; combined with active infection, especially inflammation of the bile duct system; female patients are pregnant or breastfeeding 7. Patients and (or) family members do not agree to participate in clinical trials.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests (blood routine, liver and kidney function, cardiac function);Alpha fetoprotein, AFP; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response;Disease control, DC;Complete remission, CR;Partial remission, PR;Stable disease,SD;Progression-free survival;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactLi Bo
Outcome results
None listed