Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY) - Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006823

Enrollment

Registered

2011-12-03

Start date

2011-12-01

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

Colorectal Cancer

Interventions

Irinotecan plus S-1 (IRSI) with biweekly cetuximab combination therapy 1)Irinotecan 100 mg/m2 day1,15, 30 biweekly until PD 2)S-1 80mg [BSA&lt

1.25m2] or 100mg [1.25m2&lt

BSA&lt

1.5m2] or 120mg [1.5m2&lt

BSA]/body/day, day 1-14, q4weeks 3)Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2) Clinically proven unresectable advanced / metastatic colorectal cancer 3) Previously received on one regimen of oxaliplatin-contained chemotherapy (contained relapse less than 6 months from adjuvant chemotherapy) 4) Presence of at least one measurable lesion (according to the RECIST ver.1.1) 5) Immunohistochemical evidence of EGFR expression, either in the primary tumor or in metastatic tumor lesion 6) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion 7) Patients unaffected prior therapy At least 4-6 weeks since prior radiotherapy At least 4 weeks since prior operation for organ At least 2 weeks since prior chemotherapy At least 2 weeks since prior immune therapy, cytokine therapy or BRM therapy 8) More than 20 years of age 9) ECOG performance status 0-1 10) Adequate organ function for study treatment WBC>=3,000mm3, neutrophils>=1,000/mm3 Platelets>=100,000/mm3 Hemoglobin>=9.0g/dl AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) Total bilirubin<=upper limit of normal (ULN)*2 Creatinine<=1.5mg/dl 11) Oral food intake possible 12) Life expectancy must be 3 months or longer after the combination therapy 13) Written informed consen+C120t

Exclusion criteria

Exclusion criteria: 1) History of severe allergy 2) Simultaneous or metachronous double cancers 3) Symptomatic brain metastasis 4) Severe infectious disease 5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 6) Paralytic or mechanical bowel obstruction 7) Massive pleural effusion or ascites 8) Wattery diarrhea 9) Patients who is receiving Atazanavir Sulfate or Flucytosine 10) Pregnant or lactating women or women of childbearing potential 11) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Disease control rate Progression free survival Overall survival Safety	—

Countries

Japan

Contacts

Public ContactYoichiro Yoshida

Fukuoka University Faculty of Medicine Gastroenterological Surgery

Outcome results

None listed

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