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Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer

Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer - Epitope Peptides with mFOLFOX6 for metastatic CRC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001791
Enrollment
100
Registered
2009-05-01
Start date
2009-01-01
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

Metastatic chemo naive colorectal cancer

Interventions

Sponsors

YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histological proven colorectal cancer 2. PS:0 to 1(ECOG performance status score) 3. One or more RECIST lesions 4. chemo-naive 5. Good function of critical organs 6. Suspect for more than 3 months alive 7. Written informed consents

Exclusion criteria

Exclusion criteria: 1. Severe heart diseases 2. Wish for pregnancy 3. Active infection 4. Steroid or immunosuppressive therapy 5. Allergy for using epitope peptides 6. Mental and nervous disorder 7. Massive pleural or abdominal effusions 8. Peripheral nervous disorder 9. Diarrhea 10. Doctors opinion

Design outcomes

Primary

MeasureTime frame
the efficacy (response rate, time to progression)

Secondary

MeasureTime frame
1. Safety 2. Over all survival 3. Induction of immune responses 4. Progression free survival

Countries

Japan

Contacts

Public ContactShoichi Hazama

YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology

hazama-jsgs@umin.ac.jp0836-22-2264

Outcome results

None listed

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