Hepatocellular Carcinoma
Conditions
Keywords
HCC, TACE-HAIC, TACE, TKIs, PD-1 Inhibitors
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.
Interventions
TACE was performed using 30 mg/m2 of epirubicin, 200 mg/m2 of carboplatin, and 4mg/m2 of MMC, mixed with 2-5 mL lipiodol. Up to 20 mL of additional pure lipiodol were injected into the tumor-feeding artery until stasis of blood flow was observed in the target artery. Repeated TACE was performed at intervals of 3-4 weeks.
The TKI therapy used in this study were lenvatinib (12 mg/d for bodyweight ⩾ 60 kg or 8 mg/d for bodyweight \<60 kg), sorafenib (400 mg twice a day) or apatinib (250-500 mg orally once daily). Administration of lenvatinib, apatinib or sorafenib was started on the first post-TACE day, and continually administered until disease progression developed or serious treatment-related toxicity occurred.
PD-1 inhibitors were intravenously administered on the first post-TACE day as follows: camrelizumab 200 mg or sintilimab 200 mg or toripalimab 240 mg or tislelizumab 200 mg, every 3-4 weeks.
The TACE-HAIC which was performed using 30 mg/m2 of epirubicin mixed with 2-5 mL lipiodol, followed by pure lipiodol. Then, a catheter was placed and fixed in the tumor feeding artery for the FOLFOX-based chemotherapy infusion at the following dosage: 85 mg/m2 of oxaliplatin infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; 400 mg/m2 of 5-FU bolus; and 2400 mg/m2 of continuous 5-FU infusion for 46 hours or 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. Repeated TACE-HAIC was performed at intervals of 3-4 weeks.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate | 24 rates | Rate of patients underwent hepatic surgery after careful evaluation when an estimated residual liver volume \>30-40% could be remained after R0 surgery by 2 experienced surgeons |
Countries
China