YCP02 trial

JRCT ID: jRCTs061180033

Registered date:04/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: resectable HCC
• Date of first enrollment: 16/01/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Preoperative and postoperative vaccination using peptides and adjuvants.

Outcome(s)

• Primary Outcome: safety

Secondary Outcome

1)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 maximum: Not applicable
• Gender: Both

Include criteria

1. 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 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: CYTLIMIC Inc.,CYTLIMIC Inc.
• Secondary ID(s): UMIN000029991