WT1 based chemoimmunotherapy

JRCT ID: jRCTc030190195

Registered date:28/01/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: advanced pancreatic cancer
• Date of first enrollment: 17/10/2018
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The patients received chemotherapy (GEM at a dose of 1,000 mg/m2 and nab-PTX at a dose of 125 mg/m2) intravenously on days 1, 8, and 15 of a 28-day cycle.
After a cycle of chemotherapy, the patients were treated with a combination of chemotherapy and WT1 peptides pulsed dendritic cells (WT1/DC) vaccine.
The WT1/DC vaccine (usually 1X10^7 cells/dose) was intradermally administered biweekly at six different sites (bilateral upper arms, lower abdomen, and femoral regions) regardless of the regimen of chemotherapy.
The patients could receive 15 times of WT1/DC vaccine until the unacceptable adverse events, or withdrawal of consent.
After disease progression, the patients were permitted to receive the second-line chemotherapy.

Outcome(s)

• Primary Outcome: 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

progression free survival (PFS), overall survival (OS), disease control rate
WT1-specific immune responses
immune responses not specific for WT1

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Human leukocyte antigen (HLA)-A*2402, A*0201, A*0206, HLA-DR (DRB1*0101, DRB1*0405, DRB1*0802, DRB1*0803, DRB1*0901, DRB1*1201, DRB1*1403, DRB1*1501, DRB1*1502, DRB5*0102), HLA-DP (DPB1*0201, DPB1*0202, DPB1*0402, DPB1*0501, DPB1*0901), or HLA-DQ(DQB1*0301, DQB1*0302, DQB1*0401, DQB1*0501, DQB1*0601, DQB1*0602-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.

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

Related Information

• Primary Sponsor: Koido Shigeo