YCP02 trial

Phase 1

• Conditions: resectable HCC

• Registration Number: JPRN-jRCTs061180033
• Lead Sponsor: agano Hiroaki

Brief Summary

Conclusions: This novel therapeutic vaccine was safe as perioperative immunotherapy for patients with HCC and has the potential to convert immunologically cold HCC tumors into hot tumors by inducing CD8+ T cell infiltration into tumors.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-04
• Study Completion: 2021-11-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion 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

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety

Secondary Outcome Measures

Name	Time	Method
1)specific CTL response in PBMC <br>2)specific CTL response in the tumor <br>3)relapse-free survival <br>4)overall survival