JRCT ID: jRCTs061180034
Registered date:04/03/2019
CpG trial
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | advanced or metastatic colorectal cancer |
Date of first enrollment | 17/05/2016 |
Target sample size | 12 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Combination Immunotherapy with peptide vaccination |
Outcome(s)
Primary Outcome | safety |
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Secondary Outcome | specific CTL response overall survival progression-free survival Response rate disease control rate Immune-related response criteria |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Colorectal cancer proven by histology or imaging (CT or MRI) 2. Patients with HLA-A*2402 3. Standard treatment failure colorectal cancer 4. Age; 20>= 5. Performance Status (PS); 0-2, 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 criteria | The 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
Primary Sponsor | Nagano Hiroaki |
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Secondary Sponsor | Hazama Shoichi |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000022082 |
Contact
Public contact | |
Name | Shoichi Hazama |
Address | 1-1-1,MinamiKogushi,Ube City Yamaguchi Japan 755-8505 |
Telephone | +81-836-22-2888 |
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 |
geka2dm@yamaguchi-u.ac.jp | |
Affiliation | Yamaguchi University Hospital |