primary hepatocellular carcinoma
Conditions
Interventions
group of TACE combined with HAIC:TACE + HAIC
group of TACE:TACE
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible). Has a radiologic diagnosis of HCC, which requires: 1) a liver mass confirmed by BICR that shows arterial phase hyperenhancement on triphasic CT or MRI, AND EITHER: 2) is >= 20 mm with either non-peripheral portal washout or an enhancing capsule, or is 10-19 mm with non-peripheral portal venous washout and an enhancing capsule. 2. Not amenable to curative treatment such as resection, ablation, or liver transplant. 3. Has at least one measurable HCC lesion based on RECIST 1.1, confirmed by BICR. 4. Has all lesions treatable with TACE in 1 or 2 (split-TACE) sessions. 5. Has a predicted life expectancy of >3 months.
Exclusion criteria
Exclusion criteria: 1. Diffuse hepatocellular carcinoma 2. HCC lesions occupying >= 70% of the liver volume. 3. Has had esophageal or gastric variceal bleeding within the last 6 months. 4. Has clinically apparent ascites on physical examination that is not controlled with medication. 5. Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy. Note: Ascites detectable on imaging studies only are allowed. 6. Has medical contraindications that preclude all forms of contrast enhanced imaging (CT or MRI). 7. Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for HCC. 8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, or CD137). 9. Has received locoregional therapy to liver (such as TACE, transarterial embolization, TARE, hepatic arterial infusion, or radiation,) for treatment of HCC. Previous use of ablation and resection are permitted if >4 weeks prior to first dose of study intervention. 10. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 11. Has a known psychiatric or substance abuse disorder that would interfere with the participants ability to cooperate with the requirements of the study. 12. Liver function, CHild Pugh, Class C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactMingzhi Hao
Fujian Provincial Cancer Hospital
Outcome results
None listed