Clinical study of intratumoral dendritic cell injection after radiofrequency ablation therapy in hepatitis C virus-related hepatocellular carcinoma patients
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-C000000451
- Lead Sponsor
- Tokyo Medical University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Rate of relapse, relapse-free survival, tumor markers, immunological parameters