hepatocellular carcinoma
Conditions
Interventions
b-HAIC group (single arm):b-HAIC (balloon-occluded HAIC)
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study by signing an informed consent form; 2. Aged >=18 years old, male or female; 3. Meet the diagnostic criteria of hepatocellular carcinoma (AASLD guidelines for the treatment of hepatocellular carcinoma); 4. Inoperable resection (including progressive hepatocellular carcinoma, hepatocellular carcinoma that is not suitable for TACE or has progressed after two cycles of TACE), without extra-hepatic metastasis, and intrahepatic lesions with obvious enhancement in arterial phase; 5. Liver function Child-Pugh Grade A and B (7 points); 6. HB (haemoglobin) >= 90 g/L; WBC (white blood cell) >= 3.0×10^9/L; PLT (platelet) >= 50×10^9/L; AST, ALT (aminotransferase) <= 5.0×ULN, T-BIL (total bilirubin) <= 1.5×ULN, CRE (creatinine) <= 1.5×ULN; 7. Eastern Cooperative Oncology Group (ECOG) physical status score <= 2; 8. Life expectancy greater than 3 months.
Exclusion criteria
Exclusion criteria: 1. Main portal vein tumor thrombus involving bilateral first-order branches of the portal vein without obvious collateral vessels; 2. Liver function Child-Pugh score >= 8; 3. Patients with organ (heart, kidney) dysfunction who are unable to tolerate HAIC treatment; 4. Patients with clear extrahepatic metastases, a history of other malignant tumors that may affect current liver cancer treatment, or active infections requiring systemic treatment (excluding HCV or HBV); 5. Patients who have undergone liver or bile duct surgery resulting in altered vascular anatomy; 6. Patients who have received immune checkpoint inhibitors (PD1 or PDL1) for more than 3 months, or recipients of allogeneic tissue/organ transplants; 7. Patients who are pregnant or lactating; 8. Patients currently participating in or previously involved in clinical trials that may interfere with the results of this trial, or where the investigator believes that participation in the study is not in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| AFP (Alpha-fetoprotein);DCR (disease control rate);PFS (progression free survival);OS (overall survival);AE (adverse event);DOR (duration of response); | — |
Countries
China
Contacts
Public ContactFeng Wang
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed