A phase I study of continuous hepatic arterial infusion of Irinotecan in patients with locally advanced hepatocellular carcinoma

2011 ◽  
Vol 43 (12) ◽  
pp. 1015-1021 ◽  
Author(s):  
Giovanni Brandi ◽  
Guido Biasco ◽  
Maria Grazia Mirarchi ◽  
Rita Golfieri ◽  
Antonello Di Paolo ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Hepatic Arterial Infusion ◽  
Advanced Hepatocellular Carcinoma ◽  
Arterial Infusion

scholarly journals Axitinib in Combination with Radiotherapy for Advanced Hepatocellular Carcinoma: A Phase I Clinical Trial

2020 ◽  
Author(s):  
Kai-Lin Yang ◽  
Mau-Shin Chi ◽  
Hui-Ling Ko ◽  
Yi-Ying Huang ◽  
Su-Chen Huang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Normal Liver ◽  
Maximum Tolerated Dose ◽  
Outcome Analysis ◽  
Advanced Hepatocellular Carcinoma ◽  
Advanced Hcc

Abstract Background: Axitinib is a selective vascular endothelial growth factor receptors 1–3 inhibitor approved for second-line treatment of advanced renal cell carcinoma. In a randomized, placebo-controlled phase II trial for patients with locally advanced or metastatic hepatocellular carcinoma (HCC), axitinib improved progression-free survival and showed overall response rate of 9.7%. This phase I study aimed at evaluating maximum tolerated dose (MTD) of axitinib in combination with radiotherapy (RT) for advanced hepatocellular carcinoma (HCC).Methods: This phase I study followed the rule of traditional 3 + 3 design. Major eligibility included: (1) advanced HCC unsuitable for surgery, radiofrequency ablation or transarterial chemoembolization; (2) failure on sorafenib or no grant for sorafenib from health insurance system. Eligible patients with advanced HCC received axitinib for total 8 weeks during and after RT. Three cohorts with axitinib dose escalation were planned: 1 mg twice daily (level I), 2 mg twice daily (level II) and 3 mg twice daily (level III). The prescribed doses of RT ranged from 37.5 to 67.5 Gy in 15 fractions to liver tumor(s) and were determined based on an upper limit of mean liver dose of 18 Gy (intended isotoxic RT for normal liver). The primary endpoint was MTD of axitinib in combination with RT.Results: Total nine eligible patients received axitinib dose levels of 1 mg twice daily (n = 3), 2 mg twice daily (n = 3) and 3 mg twice daily (n = 3). Dose-limiting toxicity (DLT) did not occur in the 3 cohorts; the MTD was defined as 3 mg twice daily in this study. ORR was 66.7%, including 3 complete responses and 3 partial responses, at 3 months after treatment initiation. With a median follow-up of 16.6 months, median OS was not reached, 1-year OS was 66.7%, and median PFS was 7.4 months.Conclusions: Axitinib in combination with RT for advanced HCC was well tolerated with an axitinib MTD of 3 mg twice daily in this study. The outcome analysis should be interpreted with caution due to the small total cohort.Trial registration: ClinicalTrials.gov (Identifier: NCT02814461), Registered June 27, 2016 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02814461

scholarly journals Clinical Benefits of Hepatic Arterial Infusion Chemotherapy for Advanced Hepatocellular Carcinoma

2021 ◽  
Vol 11 (4) ◽  
pp. 1882
Author(s):  
Takahiro Yamasaki ◽  
Issei Saeki ◽  
Yurika Kotoh-Yamauchi ◽  
Ryo Sasaki ◽  
Norikazu Tanabe ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Vascular Invasion ◽  
Hepatic Arterial Infusion ◽  
Hepatic Arterial Infusion Chemotherapy ◽  
Advanced Hepatocellular Carcinoma ◽  
Arterial Infusion ◽  
Arterial Infusion Chemotherapy ◽  
Infusion Chemotherapy ◽  
Recent Success ◽  
Clinical Benefits

Recent success of systemic therapeutic agents, including combination immunotherapy, could promote a change in the treatment strategy in patients with advanced hepatocellular carcinoma (HCC). Although hepatic arterial infusion chemotherapy (HAIC) is a treatment option for advanced HCC in Japan, it is not recommended by other guidelines. We discuss the clinical benefits of HAIC compared to sorafenib. The clinical benefits of HAIC are as follows: (1) even a patient with Child–Pugh B HCC (7 or 8 points) is a candidate for HAIC (2) Child–Pugh scores barely decline with the use of HAIC compared with sorafenib (3) HAIC is highly effective in patients with vascular invasion compared with sorafenib; and (4) survival in patients receiving HAIC may not be associated with skeletal muscle volume. In contrast, the disadvantages are problems related with the reservoir system. HAIC has clinical benefits in a subpopulation of patients without extrahepatic metastasis with Child–Pugh A HCC and vascular invasion (especially primary branch invasion or main portal vein invasion) or with Child–Pugh B HCC.

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