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Phase 1 Study of Gemcitabine With Vaccine Therapy Targeting Tumor Antigen, URLC10, For The Patients With Unresectable or Recurrent Bile Duct Cancer

Phase 1
20 Years
80 Years
Open (Enrolling)
Bile Duct Cancer

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Trial Information

Phase 1 Study of Gemcitabine With Vaccine Therapy Targeting Tumor Antigen, URLC10, For The Patients With Unresectable or Recurrent Bile Duct Cancer

Our previous studies have demonstrated that up-regulated lung cancer 10 (URLC10) has been
identified as a new target of tumor associated antigen using cDNA microarray technique
combined with the expression profiles of normal and cancer tissues. We have also found that
100% of tissue samples from bile duct cancer express URLC10. We have determined the
HLA-A*2402 and HLA-A*0201 restricted epitope peptides derived from URLC10.These epitope
peptides have shown to induce specific Cytotoxic T Lymphocytes (CTL). Furthermore, 60% and
20% of Japanese population have HLA-A*2402 and HLA-A*0201, respectively. Therefore, these
peptides are suitable for clinical trial. On the other hand, gemcitabine is a drug approved
against bile duct cancer. Recent studies has reported that gemcitabine has an additional
ability to improve immune response. From these results, synergistic effect between vaccine
therapy and chemotherapy using gemcitabine will be expected.

In this clinical trial, we evaluate the safety, tolerability, and immune responses of
different doses of URLC10 peptide emulsified with Montanide ISA51 as immunochemotherapy in
the patients with unresectable or recurrent bile duct cancer. Toxicity profiles will be
monitored, and antigen specific T cell responses will be described.

Inclusion Criteria:


1. Advanced bile duct cancer precluding curative surgical resection and recurrent bile
duct cancer

2. measurable disease by CT scan, ultrasonography, or other imaging modalities.


1. ECOG performance status 0-2

2. Life expectancy >3 months

3. Laboratory values as follows 2,000/mm³< WBC < 15,000/mm³ Platelet count ≥ 75,000/mm³
Bilirubin ≤ 1.5 x the institutional normal upper limits AST, ALT, ALP ≤ 2.5 x the
institutional normal upper limits Creatinine ≤ 1.5 x the institutional normal upper

4. HLA-A*2402 or HLA-A*0201

5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective
means of contraception)

2. Breastfeeding

3. Serious or uncontrolled infection

4. Prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4

5. Other malignancy within 5 years prior to entry into the study

6. Concomitant treatment with steroids or immunosuppressing agent

7. Disease to the central nervous system

8. Decision of unsuitableness by principal investigator or physician-in-charge

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (toxicities as assessed by NCI CTCAE version 3)

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Yuzo Yamamoto, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Gastroenterological Surgery, Akita University, School of Medicine


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

February 2008

Completion Date:

August 2012

Related Keywords:

  • Bile Duct Cancer
  • Bile Duct Neoplasms