Phase-I/IIa study of radiofrequency ablation combined with in situ application of immunoadjuvant, Cal-TUMP

UMIN ID: UMIN000000767

Registered date:01/04/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 2007/04/01
• Target sample size: 16
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Adjuvant

Outcome(s)

• Primary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria 1) Past history of other caner except hepatocellular carcinoma in recent 5 year, or present affecting cancer 2) Past history of autoimmune disease or present affecting autoimmune disease 3) Infected HIV 4) Technically difficult main tumor for radiofrequency ablation 5) Difficult for this treatment because of hematological disease or bleeding tendency 6) Uncontrolled diseases such as sever infectious disease, severe cardiac disease and psychological diseases 7) (1) Systemic administration of anti-cancer drugs or steroid, (2) Radiological or biological treatment which may affect to systemic condition, within 4 weeks before this treatment 8) Pregnant or nursing woman or person who has the possibility of pregnancy and plan to pregnant 9)Affecting tuberculosis, or more than 2 cm in diameter induration reaction positive after skin reaction test using immune adjuvant specially made in our hospital 10) inadequate cases by principle doctor including uncertainty to adherent to treatment protocol

Related Information

• Primary Sponsor: Kanazawa university
• Secondary Sponsor: Kasumigaura Hospital Tokyo Medical University
• Source(s) of Monetary Support: Kanazawa university,Cell Medicine Co. Ltd