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Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer

Phase 1 trial of Oxaliplatin/IRInotecan/S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer - HGCSG1403

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017002
Enrollment
18
Registered
2015-04-01
Start date
2015-11-02
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

unresectable pancreatic cancer

Interventions

Sponsors

Hokkaido University Hospital Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically diagnosed invasive ductal carcinoma 2) Unresectable locally advanced, metastatic, or recurrent disease 3) No prior chemotherapy or radiotherapy for pancreatic cancer 4) Aged 20 to 75 years old 5) ECOG PS of 0 or 1 6) Adequate organ functions 7) Sufficient oral intake 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Grade 2 or greater peripheral neuropathy 2) Having UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28 gene 3) Moderate ascites 4)Intestinal pneumonitis or pulmonary fibrosis 5) Uncontrollable diarrhea 6) Serious complications (organ failure, uncontrolled diabetes mellitus, active infection, ulcer, ileus, mental disorders, or central nervous system disorders) 8) Active double cancer 9) Pregnancy 10)Inappropriate for this study judged by the attending physician

Design outcomes

Primary

MeasureTime frame
frequency of DLT (Dose Limiting Toxicity) , determination of MTD (Maximum Tolerated Dose)

Secondary

MeasureTime frame
the frequency of side effect, response rate, progression-free survival, overall survival

Countries

Japan

Contacts

Public ContactYasuyuki Kawamoto

Hokkaido University Hospital Gastroenterology and Hepatology

y-kawamoto0716@hotmail.co.jp011-716-1161

Outcome results

None listed

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