WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study

WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study - Advanced pancreatic cancer GEM+WT1 vaccine RCT P2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005248

Enrollment

150

Registered

2011-04-01

Start date

2011-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Combination therapy with GEM+WT1 vaccine 1) Gemcitabine: 1000mg/m2, day1, 8, 15, q28 intravenous injection, 30min. 2) WT1 peptide-based cancer vaccine: 3mg of WT1 peptide/body, day1, day15, q28 int

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed as pancreatic cancer 2) unresectable (UICC-stage III or IV) or recurrent pancreatic cnacer 3) Histologically or Cytologically proven pancreatic ductal adenocarcinoma 4) Karnofsky Performance Status 80-100% 5) Aged 20 to 79 years old 6) HLA-A*2402, A*0201 7) Without CNS metastases 8) Without moderate or more ascites / pleuraleffusion 9) No previous treatment against unresectable or recurrent advanced pancreatic cancer 10) No previous operation, chemotheraoy, or radiotherapy against any other malignancies, and no recurrence at least within 5 years 11) Able to eat by mouth 12) Adequate organ function 13) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers, with exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women fo childearing potential, and men who want to get partner pregnat 3) Psychosis 4) Patients requiring systemic immunosuppresive agents, or moderate or higher dose of steroid with exception of usage for cancer pain 5) Pulmonary fibrosis or interstitial pneumonitis 6) Active bacterial or fungal infection 7) Severe complications 8) MDS, MDS/MPD, MPD 9) Severe drug allergy 10) Inadequate physical condition, as diagnosed by the primary physician

Design outcomes

Primary

Measure	Time frame
1-year overall survival rate	—

Secondary

Measure	Time frame
Overall Survival(OS), 6-month OS rate, 1.5-year OS rate, Progression Free Survival, Disease control rate, Clinical benefit response, QOL, toxic effects, immunological monitoring, and non-immunological monitorings	—

Countries

Japan

Contacts

Public ContactSumiyuki Nishida

Osaka university Graduate school of Medicine Cancer Immunotherapy

sumiyuki-n@imed3.med.osaka-u.ac.jp06-6879-3676

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026