NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180058

Registered date:18/03/2019

YNP01 trial

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedpatients with advanced or metastatic solid cancer
Date of first enrollment12/01/2016
Target sample size18
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Combination Immunotherapy with peptide vaccination

Outcome(s)

Primary Outcomesafety
Secondary Outcomespecific CTL response Antitumor effect(OS PFS CR+PR CR+PR+SD) Immune-related response criteria

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1.patients with advanced or metastatic solid cancer (Pancreatic cancer, colon cancer, gastric cancer, esophageal cancer, liver cancer and breast cancer) proven by histology or imaging (CT or MRI) 2. Patients with HLA-A*2402 -A*0201 -A*0206 3. Standard treatment failure cancer 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,MinamiKogushi,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,MinamiKogushi,Ube City Yamaguchi Japan 755-8505
Telephone +81-836-22-2264
E-mail geka2dm@yamaguchi-u.ac.jp
Affiliation Yamaguchi University Hospital