A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy.

A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy. - A Phase II Study of Tri-weekly XELIRI with Bevacizumab for patient with unresectable or recurrent Colorectal Cancer as first -line chemotherapy.(KSCC1101)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006070

Enrollment

Registered

2011-07-29

Start date

2011-07-12

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

Colorectal Cancer

Interventions

Tri-weekly XELIRI+ bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.written informed consent 2.appropriate for the study at the physician's assessment 3. histological confirmation of colorectal cancer. 4.no prior chemotherapy for the patients with unresectable or recurrent colorectal cancer 5.aged 20<= years. 6.ecog performance status of 0-1. 7.at least one measurable lesion based on the recist criterion. (within 28 days before registration) 8.life expectancy at least 3 months. 9.required baseline laboratory parameters (within 14 days before registration): wbc more than 3000 and wbc less than 12000/mm3 neu more than 1,500/ mm3 plt more than 100,000/ mm3 hb more than 9.0g/dl t-bil less than 1.5mg/dl ast and alt <= 100IU/l (200iu/i in case of liver metastasis) cre less than 1.5mg/dl urinary protein less than grade1 (+1 or 0.15-1.0g/24h) patients with ugt1a1 genotype wild type and *6,*28 heterozygote

Exclusion criteria

Exclusion criteria: 1.co-mobility, such as infection, heart failure, history of cardiac infarction, liver cirrhosis, viral hepatitis type b , jaundice, kidney failure, uncontrolled hypertension, diabetes, interstitial lung disease, lung fibrosis, pulmonary emphysema. 2.coelomic fluid which need therapy( pleural effusion, abdominal dropsy, pericardial fluid) 3.history of the severe hypersensitivity 4.active other malignancies. 5.history of mental disorder, central nerve disorder, cerebral vascular disorder. 6. prior radiotherapy for primary and metastases tumors 7.brain metastasis 8.evidence of bleeding diathesis, intestinal paralysis , ileus, peptic ulcer, traumatic bone fracture 9.watery stools or grade 2 or more diarrhea 10. requiring anti-thrombogenic therapy to prevent thrombosis 11.requiring immunosuppressant and steroid drug 12. receiving atazanavir sulfate 13.pregnant or lactating woman 14. treatment history of irinotecan 15.not appropriate for the study at the physician's assessment

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival Time to treatment failure Time to failure of strategy Overall survival Safety Investigation of Nausea and vomiting Quality of life	—

Countries

Japan

Contacts

Public ContactKSCC Secretariat

clinical research support center Kyushu KSCC Secretariat

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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