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Anticancer effects of vitamin K combined with transarterial chemoembolization in hepatocellular carcinoma, a randomized controlled trial.

  • 2025-04-22
  • British journal of cancer 132(12)
    • Yoshimichi Haruna
    • Takayuki Yakushijin
    • Miho Yamakawa
    • Tetsuo Nakazawa

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 51
Population
patients with unresectable HCC
Methods
randomized controlled trial, assigning patients (1:1) to TACE + vitamin K or TACE alone groups

Background

We have previously reported that vitamin K dosing augments the anticancer effects of sorafenib by suppressing levels of des-γ-carboxy prothrombin, a known tumor growth and angiogenesis factor produced in HCC under sorafenib-induced ischemia. Herein, we aimed to establish whether vitamin K dosing could afford a similar anticancer effect when combined with transarterial chemoembolization (TACE).

Methods

We performed a randomized controlled trial, assigning patients with unresectable HCC (1:1) to TACE + vitamin K or TACE alone groups. Co-primary endpoints were objective response rate and PFS; the secondary endpoint was safety.

Results

The TACE + vitamin K group (n = 50) exhibited a significantly higher objective response rate than the TACE alone group (n = 51) (96.0% vs. 82.4%, p = 0.028). The PFS was significantly longer in the TACE + vitamin K group than that in the TACE alone group (median time: 262 days [95% confidence interval (CI), 35.8-488.2 days] vs. 146 days [95% CI, 111.6-180.4 days]; p = 0.013, hazard ratio: 0.55 [95% CI, 0.34-0.89]). There were no significant differences in the incidence of adverse events between groups.

Conclusions

Compared with TACE alone, vitamin K dosing combined with TACE improved anticancer outcomes.

Clinical trial number

UMIN000026404.

Research Insights

  • Vitamin K→Improved Objective Response Rate

    The TACE + vitamin K group (n = 50) exhibited a significantly higher objective response rate than the TACE alone group (n = 51) (96.0% vs. 82.4%, p = 0.028).

    Effect
    Beneficial
    Effect size
    Moderate
  • Vitamin K→Improved Progression-free Survival

    The PFS was significantly longer in the TACE + vitamin K group than that in the TACE alone group (median time: 262 days [95% confidence interval (CI), 35.8-488.2 days] vs. 146 days [95% CI, 111.6-180.4 days]; p = 0.013, hazard ratio: 0.55 [95% CI, 0.34-0.89]).

    Effect
    Beneficial
    Effect size
    Moderate
  • Vitamin K→Reduced Adverse Event

    There were no significant differences in the incidence of adverse events between groups.

    Effect
    Neutral
    Effect size
    Small

Adverse Events Reported

  • Vitamin K→Overall tolerability

    There were no significant differences in the incidence of adverse events between groups.

    Finding
    No significant difference
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