Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab

Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab - Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009734

Enrollment

Registered

2013-01-14

Start date

2012-10-02

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

Colorectal cancer

Interventions

S-1/irinotecan combination therapy Irinotecan 100 mg/m2(day1,15), S-1 80-120mg/day, PO from day1 to day 14 of each 28 day cycle.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced/recurrent colorectal cancer 2) KRAS mutation type 3) Age 20 years<= 80 4) Patients who had previously received on irinotecan, oxaliplatin and fluoropyrimidine,bevacizumab 5) ECOG performance status 0-1 6) Presence of measurable lesion judged by enhanced CT (according to the RECIST 1.1) 7) Patiens have enough organ function based on blood test within 28day before registration. 1.WBC>=3,000/mm3<=12,000/mm3 2.Neurtophils>=1,500/mm3 3. Platelets>=100,000/mm3 4. Hemoglobin>=9.0g/dl 5. Total bilirubin<=2.0mg/dl 6.AST<=100IU/L(ALT<=200IU/L with liver metastases) 7.ALT<=100IU/L(ALT<=200IU/L with liver metastases) 8. Creatinine<=1.2mg/dl 9. creatinine clearance>=50ml/min 8)Be able to take oral drugs 9)Life expectancy at least 3 months 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1) With contraindicate S-1 2) Patients under treatment with flucytosine,phenytoin,warfarin potassium. 3) Severe bone marrow suppression 4) Active infection and inflammation 5)Comorbidity or history of interstitial lung disease or pulmonary fibrosis 6) Watery stools or diarrhea 7) Severe complications 8)Simultaneous or metachronous double cancers 9)Pregnant or lactating women or women of childbearing potential 10) Other patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

Measure	Time frame
Progression free survival(PFS)	—

Secondary

Measure	Time frame
Overall response rate Overall survival Disease control rate (CR+PR+SD) Safety	—

Countries

Japan

Contacts

Public ContactKenji Kastumata

Tokyo Medical University 3rd department of surgery

k-katsu@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

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