Hepatocellular carcinoma
Conditions
Interventions
Single-arm:Hepatic arterial infusion chemotherapy
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75, male or female; 2. Patients who meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (Version 2022) or are confirmed with primary hepatocellular carcinoma by histopathological or cytological examination, and have at least one measurable intrahepatic target lesion. After three or more consecutive standardized and refined TACE treatments, TACE was evaluated in patients whose target lesions for intrahepatic treatment were still disease progression compared with those before the first TACE treatment, through enhanced CT/MR examination and evaluation based on mRECIST c criteria within 1–3 months after each operation; 3. After the occurrence of TACE refractoriness, the CNLC will be divided into stages Ib to III b; 4. Routine blood test: WBC >= 3.0*10^9/L, and PLT >=50*10^9/L; 5. ECOG score is 0–1 point. Liver function was graded as Child-Pugh A or B, or achieved by medical treatment; 6. The pathological result is hepatocellular carcinoma (HCC) or either Contrast-enhanced ultrasound, dynamic contrast-enhanced CT, dynamic contrast-enhanced MRI of Gd-DTPA, or dynamic contrast-enhanced MRI of Gd-EOB-DTPA has one of the typical characteristics of hepatocellular carcinoma; 7. Understand and sign the informed consent form; 8. After Multidisciplinary team( MDT) discussion.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation or other malignant tumors; 3. Patients with consciousness disorder or can't cooperate with treatment, combined with mental illness patients; 4. Patients who have participated in other clinical trials in recent three months; 5. Phase 1A, with ablation indications remaining; 6. Liver function was graded as Child-Pugh C, which could not be improved after liver protection treatment; 7. Esophageal (gastric) variceal bleeding occurs within one month before treatment; 8. Irreversible coagulation disorder and severe hemogram abnormality with severe bleeding tendency. Platelet count < 50*10^9/L and severe coagulation dysfunction cannot tolerate perfusion chemotherapy; 9. Refractory massive ascites, cachexia; 10. Active infection, especially inflammation of the biliary system, etc; 11. Severe liver, kidney, heart, lung, brain and other major organ failures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactJingyao Huang
Fujian Medical University Union Hospital
Outcome results
None listed