Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer

Phase I trial of capecitabine, oxaliplatin and irinotecan combination chemotherapy (XELOXIRI) for advanced gastric cancer - Phase I trial of XELOXIRI for advanced gastric cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022861

Enrollment

Registered

2016-06-24

Start date

2016-06-27

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

Advanced gastric cancer

Interventions

Combination chemotherapy with capecitabine, oxaliplatin and irinotecan. Oxaliplatin and irinotecan are administered on day1. Capecitabine is taken orally from day1 to day14. Increasing dose of irinote

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven advanced / recurrent gastric cancer 2) Possible for oral intake and medication 3) Evaluable legions 4) No history of chemotherapy, immunotherapy or radiotherapy 5) ECOG performance status 0 or 1 6) No major complications 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) HER2 positive 2) UGT1A1 *6 or *28 homozygote or *6 and *28 heterozygote 3) Symptomatic brain metastasis 4) Infectious disease 5) Grade 2 or more diarrhea 6) Grade 2 or more peripheral sensory neuropathy 7) Massive pleural effusion, ascites, or cardiac effusion 8) Ileus 9) Defined interstitial pneumonia

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity	—

Secondary

Measure	Time frame
objective response rate disease control rate adverse event	—

Countries

Japan

Contacts

Public ContactShingo Tamura

Kyushu Medical Center Department of Clinical Oncology

tamshin@me.com092-852-0700

Outcome results

None listed

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