Phase II study of bevacizumab and irinotecan plus alternate-day S-1 as second-line therapy in patients with metastatic colorectal cancer.

Phase II study of bevacizumab and irinotecan plus alternate-day S-1 as second-line therapy in patients with metastatic colorectal cancer. - AIRS study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008947

Enrollment

Registered

2012-09-19

Start date

2012-06-01

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

Alternate-day S-1 (80mg/m2

day 2,4,6...14) combined with irinotecan (150mg/m2

day 1) and bevacizumab (5.0 mg/kg

day 1)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed colorectal cancer (adenocarcinoma) 2) Unresectabler metastatic colorectal cancer 3) Age, 20 years old and above 4) ECOG performance status of 0-1 5) One prior first line chemotherapy consisting of fluoropyrimidine (except TS-1) and oxaliplatin with or without bevacizumab 6) Adequate organ function within 14 days before registration a)WBC=>3000/mm3 b)Neutrophil=>1500/mm3 c)Platelet count=>100000/mm3 d)Hemoglobin=>9.0 g/dL e)AST ALT <= 100 IU/L (Liver Met;AST ALT<= 200 IU/L ) f)Total bilirubin <= 1.5 mg/dL g)Creatinine clearance => 40 mL/min h)Urine protein <=1+ PT-INR <=1+ 7) Able to receive oral treatment 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1)History of serious drug hypersensitivity 2)Active infections 3) Serious complications (interstitial pneumonitis, pulmonary fibrosis, renal failure, liver dysfunction, poorly controlled DM, poorly controlled hypertension) 4) Distinctly abnormal ECG or cardiovascular disease (heart failure, myocardial infarction, angina) 5) Massive pleural effusion or ascites 6) Ongoing treatment with Flucytosine, Phenytoin or Warfarin potassium 7) Synchronous or metachronous malignancy except carcinoma in situ 8) Prior radiotherapy 9) Diarrhea 10) Active hepatitis type HBs positive 11) History of thromboembolism, brain infarction, pulmonary infarction and interstitial pneumonitis 12) GI perforation or hemorrhage 13) Peritoneal metastasis 14) Brain metastasis 15)Pregnant or possibly pregnant women 16) Men who want get partner pregnant. 17) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Incidence of grade 3 or 4 diarrhea	—

Secondary

Measure	Time frame
Response rate, Disease-cintrol rate, Overall survival, Progression-free survival, Time to treatment failure, Treatment completion rate, Safety	—

Countries

Japan

Contacts

Public ContactYumi Miyashita

Epidemiological and Clinical research Information Network (ECRIN) ECRIN Data Center

miya@ecrin.or.jp0564-64-7300

Outcome results

None listed

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