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Background <p>Most adjuvant therapies for hepatocellular carcinoma (HCC) have failed except for autologous cytokine-induced killer (CIK) therapy, which prolonged recurrence-free survival (RFS) in a previously reported randomized controlled trial (RCT) and real-world data (RWD).</p> Methods <p>This study aimed to assess the long-term outcomes of adjuvant CIK therapy using both an extended follow-up of the original RCT and a retrospective cohort study. An extended follow-up analysis of the RCT included 226 patients (114 in the CIK group and 112 in the control group). The follow-up duration was extended from 2 to 9&#xa0;years after the enrollment of the last patient. In parallel, a retrospective RWD study was performed involving 577 patients from two tertiary centers in Korea, including 251 who received adjuvant CIK therapy and 326 controls. Propensity score matching (PSM) was applied to adjust for baseline imbalances. The primary endpoint was RFS in both studies.</p> Results <p>In the RWD study (median follow-up = 57.2&#xa0;months), the CIK group demonstrated significantly prolonged RFS than controls both before PSM (median = 101.2 versus 64.7&#xa0;months; HR = 0.69, 95% CI 0.53–0.90, <i>P</i> = 0.006) and after PSM (median = 101.2 vs. 65.7&#xa0;months; HR = 0.64, 95% CI 0.45–0.91, <i>P</i> = 0.01). In the extended follow-up of the RCT (median follow-up = 116.1&#xa0;months), the CIK group exhibited significantly prolonged RFS (median = 44.0 vs. 30.0&#xa0;months; hazard ratio [HR] = 0.72, 95% confidence interval [CI] 0.54–0.97, <i>P</i> = 0.033) compared to the control group.</p> Conclusions <p>Adjuvant CIK cell therapy significantly improved RFS in both a RWD study and a 9-year extended RCT follow-up, supporting its reproducible benefit in reducing recurrence after curative treatment of HCC. These consistent findings provide strong evidence for the clinical utility of CIK therapy as a durable adjuvant immunotherapeutic strategy for HCC.</p>

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Adjuvant cytokine-induced killer cell immunotherapy in hepatocellular carcinoma: real-world data and 9-year extended follow-up of a randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月27日

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  • Hyunjae Shin,
  • Youngsu Park,
  • Byeong Geun Song,
  • Won-Mook Choi,
  • Hyung Joon Han,
  • Youngwoo Lee,
  • Tae-Jin Song,
  • Jong-Eun Yeon,
  • Young-Suk Lim,
  • Moon Haeng Hur,
  • Yun Bin Lee,
  • Eun Ju Cho,
  • Su Jong Yu,
  • Yoon Jun Kim,
  • Joon Hyeok Lee,
  • Jung-Hwan Yoon,
  • Jeong-Hoon Lee

摘要

Background

Most adjuvant therapies for hepatocellular carcinoma (HCC) have failed except for autologous cytokine-induced killer (CIK) therapy, which prolonged recurrence-free survival (RFS) in a previously reported randomized controlled trial (RCT) and real-world data (RWD).

Methods

This study aimed to assess the long-term outcomes of adjuvant CIK therapy using both an extended follow-up of the original RCT and a retrospective cohort study. An extended follow-up analysis of the RCT included 226 patients (114 in the CIK group and 112 in the control group). The follow-up duration was extended from 2 to 9 years after the enrollment of the last patient. In parallel, a retrospective RWD study was performed involving 577 patients from two tertiary centers in Korea, including 251 who received adjuvant CIK therapy and 326 controls. Propensity score matching (PSM) was applied to adjust for baseline imbalances. The primary endpoint was RFS in both studies.

Results

In the RWD study (median follow-up = 57.2 months), the CIK group demonstrated significantly prolonged RFS than controls both before PSM (median = 101.2 versus 64.7 months; HR = 0.69, 95% CI 0.53–0.90, P = 0.006) and after PSM (median = 101.2 vs. 65.7 months; HR = 0.64, 95% CI 0.45–0.91, P = 0.01). In the extended follow-up of the RCT (median follow-up = 116.1 months), the CIK group exhibited significantly prolonged RFS (median = 44.0 vs. 30.0 months; hazard ratio [HR] = 0.72, 95% confidence interval [CI] 0.54–0.97, P = 0.033) compared to the control group.

Conclusions

Adjuvant CIK cell therapy significantly improved RFS in both a RWD study and a 9-year extended RCT follow-up, supporting its reproducible benefit in reducing recurrence after curative treatment of HCC. These consistent findings provide strong evidence for the clinical utility of CIK therapy as a durable adjuvant immunotherapeutic strategy for HCC.