eoantigen based chemoimmunotherapy

Phase 1

Recruiting

• Conditions: advanced pancreatic cancer; pancreatic cancer, neoantigen, dendritic cell, cancer vaccines

• Registration Number: JPRN-jRCTc030190081
• Lead Sponsor: Koido Shigeo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Human leukocyte antigen (HLA)-A*02:01- or A*24:02-positive patients.
Patients with histologically or cytologically confirmed locally advanced or metastatic pancreatic cancer, or recurrent disease after surgery.
Patients with ages between 20 and 75 years.
Karnofsky performance status (KPS) of 80% to 100%.
Patients with a KPS of 70% were also included but only if KPS was decreased by poorly controlled cancerous pain at enrollment.
Patients had adequate hematologic, hepatic, and renal function.
Patients had a life expectancy of at least 3 months.
All patients provided written informed consent.

Exclusion Criteria

The exclusion criteria were pregnancy, serious infections, severe underlying disease, severe allergic disease, and a judgment of unsuitability by the principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint was the assessment of the safety and toxicity of the combination therapy based on the Common Terminology Criteria for Adverse Events (CTCAE).

Secondary Outcome Measures

Name	Time	Method
progression free survival (PFS), overall survival (OS), disease control rate<br>neoantigen-specific immune responses<br>immune responses not specific for neoantigen