Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type

Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type - Study of Bevacizumab + Irinotecan + S-1 therapy in metastatic colorectal cancer with KRAS mutant type

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004630

Enrollment

Registered

2010-11-30

Start date

2010-11-01

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

Metastatic colorectal cancer

Interventions

IRIS + Bevacizumab Bevacizumab 5mg/kg/biweekly Irinotecan 100 mg/m2/biweekly S-1 80,100,120 mg/twice/day 1-14, following two weeks off

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with histologically proven colorectal cancer (2) Metastatic colorectal cancer (3) KRAS mutant type (4) Patients with comfirmed target lesion (5) No prior chemotherapy for metastatic colorectal cancer (6) Life expectancy of more than 3 months (7) Age over 20 (8) ECOG Performance Status 0-1 (9) Patients have enough organ function for study treatment. (10) Enable to internal use (11) Written informed consent

Exclusion criteria

Exclusion criteria: (1) History of severe allergy (2) Active double cancer (3) Severe infectious disease (4) Intestinal tract paralysis or intestinal obstruction (5) Uncontrolled hypertention (6) Sever comorbidity(interstitial lung disease or pulmonary fibrosis, heart failure, renal failure, liver failure, etc) (7) Massive pleural or abdominal effusion (8) Patient with the diarrhea (9) Symptomatic brain metastases (10) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test (11) Severe mental disorder (12) Systemic administration of corticosteroids (13) Uric protein 2+ (14) Prior radiotherapy for primary and metastases tumors (15) Thrombosis, cerebral infraction, cardiac infraction or pulmonary infraction within 6 months (16) Patients who underwent surgery within 4 weeks (17) Systemic administration of antiplatelet drug (18) Patients with known bleeding disorders or clotting disorder (19) Any other cases who are regarded as inadequate for study enrollmet by investigators

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Progression Free Survival(PFS) Overall Survival(OS) Safety Best response: % change at baseline	—

Countries

Japan

Contacts

Public ContactToshiki Masuishi

Tsuchiura kyodo general hospital Department of Gastroenterology

Outcome results

None listed

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