Clinical study of intratumoral dendritic cell injection after radiofrequency ablation therapy in hepatitis C virus-related hepatocellular carcinoma patients - Combination of RFA and intratumoral DC injection for the treatment of HCC
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
Two patients with hepatocellular carcinoma (HCC) received intratumoral injection of dendritic cells(DC) after radiofrequency ablation therapy (RFA). One patient developed severe interstitial pneumonitis after DC injection. The patient promptly received steroid pulse therapy and recovered well from this severe adverse event. Because an association between interstitial pneumonitis and DC injection could not be ruled out, the study was stopped temporarily and new study was conducted (UMIN000000971) to examine the safety of DC injection in advanced HCC rather than primary or early stage HCC patients. DCs were injected into the tumor after RFA in three advanced HCC patients. The intratumoral DC injections were safe and feasible and no severe adverse event was observed in these three patients. These results indicated the interstitial pneumonitis was likely due to the patient's specific reaction in that particular patient.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients who have: uncontrolled infections, active autoimmune diseases, serious cardiac disease and other cancers; who have received continuous systemic steroids; who are pregnant, to be pregnant, or nursing mothers, and whom principle investigator or co-investigator judged to be inappropriate to participate in this study
