YNP01 trial

JRCT ID: jRCTs061180058

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: patients with advanced or metastatic solid cancer
• Date of first enrollment: 12/01/2016
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Combination Immunotherapy with peptide vaccination

Outcome(s)

• Primary Outcome: safety

Secondary Outcome

specific CTL response
Antitumor effect(OS PFS CR+PR CR+PR+SD)
Immune-related response criteria

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.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 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
• Secondary Sponsor: Hazama Shoichi
• Source(s) of Monetary Support: NEC Corporation,CYTLIMIC Inc.
• Secondary ID(s): UMIN000020440