NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180033

Registered date:04/03/2019

YCP02 trial

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedresectable HCC
Date of first enrollment16/01/2018
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Preoperative and postoperative vaccination using peptides and adjuvants.

Outcome(s)

Primary Outcomesafety
Secondary Outcome1)specific CTL response in PBMC 2)specific CTL response in the tumor 3)relapse-free survival 4)overall survival

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. HCC proven by histology or imaging (CT or MRI) 2. Patients with HLA-A*2402, -A*0201, -A*0206 3. HCC with clinical Stage II-Iva, without cVp2, cVv2, which may be performed curative resection 4. Age; 20>= 5. Performance Status (PS); 0-1, Eastern Cooperative Oncology Group (ECOG) 6. Preserved organ functions (number of WBCs more than 2.0x103/mm3; % of lymphocyte >=15; number of platelets >=7.5x103/mm3; hemoglobin >=8.0 g/ dl; creatinine <=2.5 times of upper normal limit) 7. Patients provided written, informed consent to participate
Exclude criteriaThe exclusion criteria were, double cancer, pneumonitis, severe allergy, severe infection, neurological disturbance, uncontrolled general diseases, heart diseases, general steroid treatment, or any prior therapies using same agents of this study.

Related Information

Contact

Public contact
Name Shoichi Hazama
Address 1-1-1,Minami Kogushi,Ube City Yamaguchi Japan 755-8505
Telephone +81-836-22-2888
E-mail hazama@yamaguchi-u.ac.jp
Affiliation Yamaguchi University School of Medicine
Scientific contact
Name Hiroaki Nagano
Address 1-1-1,Minami Kogushi,Ube City Yamaguchi Japan 755-8505
Telephone +81-836-22-2264
E-mail geka2dm@yamaguchi-u.ac.jp
Affiliation Yamaguchi University Hospital