Phase II study of combination chemotherapy with TS-1/irinotecan and bevacizumab as second-line therapy in patient with K-RAS mutation-type metastatic colorectal cancer

Phase II study of combination chemotherapy with TS-1/irinotecan and bevacizumab as second-line therapy in patient with K-RAS mutation-type metastatic colorectal cancer - SRIM study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005900

Enrollment

Registered

2011-07-01

Start date

2011-07-01

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

advanced/metastatic colorectal cancer

Interventions

TS-1+CPT-11+Bevacizumab TS-1 : 80,100,120mg/twice/day1-14,following two weeks off CPT-11 : 100mg/m2/biweekly Bevacizumab : 5mg/kg/biweekly

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed colorectal cancer (2) Previously received chemotherapy containing oxaliplatin (3) KRAS mutation-type (4) Patient not influenced by prior chemotherapy (5) age 20-80 years patients (6) ECOG performance status 0 or 1 (7) Patients with confirmed target lesion (8) Enable to internal use (9) Patients have enough organ function for study treatment WBC 3,000/mm3-12,000/mm3 Neutrophils >=1,500/mm3 Platelets >=100,000/mm3 Hemoglobin >=9.0g/dl Total bilirubin <=1.5mg/dl AST and ALT <=100IU/l Creatinine <1.2mg/dl Creatinine Clearance >=60ml/min Uric protein <=1+ INR <=1.5 (10) Life expectancy of more than 3months (11) Written informed consent

Exclusion criteria

Exclusion criteria: (1) History of serious drug hypersensitivity (2) Women who are pregnant,lactating,or wish to become pregnant or men who expect babies. (3) Severe infectious disease (4) Serious complications (5) Clinically significant heart disease (6) Gastrointestinal ulceration or bleeding (7) Watery diarrhea (8) Uncontrolable pleural effusion or ascites requiring (9) Symptomatic brain metastases (10) Current or previous (within the last 6months) history of GI perforation (11) Previous history of thrombosis,cerebral infarction,pulmonary infarction,hemoptysis and interstitial pneumonia (12) were operated within 28days before entry (13) Evidence of bleeding diathesis or coagulopathy (14) ongoing treatment with anticoagulant (15) had active double cancer (16) Systemic administration of corticosteroids (17) Patients judged inappropriate for this study by physicians

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Countries

Japan

Contacts

Public ContactEiji Mekata

Shiga University of Medical Science Department of Surgery

hqchemo@belle.shiga-med.ac.jp077-548-2238

Outcome results

None listed

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