TACE-HAIC Combined With Targeted Therapy and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Propensity Score Matching Study
Overview
- Phase
- Not Applicable
- Intervention
- TACE-HAIC
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Yunfei Yuan
- Enrollment
- 743
- Locations
- 1
- Primary Endpoint
- Tumor Response
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Hepatocellular carcinoma (HCC) is characterized with vascular invasion, particularly of the portal vein, resulting in portal vein tumor thrombus (PVTT) in 10%-40% of HCC patients at the time of HCC diagnosis. The prognosis of these patients is extremely poor.Treatment efficacy and safety using a combined therapy (TACE-HAIC combined with TKIs and PD-1 inhibitors) were compared with TACE alone in treatment of HCC patients with PVTT.
Investigators
Yunfei Yuan
Professor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •(a) HCC patients with PVTT (Vp1-4) treated by TACE, or the combination therapy (TACE-HAIC combined with TKIs or an PD-1 inhibitors) as initial treatment; (b) age between 18 and 75 years; (c) Child-Pugh A or B liver function; (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; (e) adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L); (f) no extrahepatic metastasis.
Exclusion Criteria
- •(a) severe underlying cardiac, pulmonary, or renal diseases; (b) history of a second primary malignant tumor; (c) incomplete medical data; (d) loss to follow-up.
Arms & Interventions
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)
Patients recieve combined with TKIs and PD-1 inhibitors
Intervention: TACE-HAIC
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)
Patients recieve combined with TKIs and PD-1 inhibitors
Intervention: Targeted therapy
Combined therapy group (TACE-HAIC combined with TKIs and PD-1 inhibitors)
Patients recieve combined with TKIs and PD-1 inhibitors
Intervention: PD-1 inhibitors
TACE alone group
TACE alone
Intervention: TACE
Outcomes
Primary Outcomes
Tumor Response
Time Frame: 24 months
The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1
Overall survival
Time Frame: 24 months
Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.
Progression-free survival
Time Frame: 24 months
Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up.
Secondary Outcomes
- Conversion rate(24 rates)