Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab

Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab - Phase II study of IRIS+BV as second-line therapy in metastatic colorectal cancer which has prior therapy of SOX + BV

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015098

Enrollment

Registered

2014-09-09

Start date

2014-06-25

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

Bevacizumab 7.5mg/kg/tri-week CPT-11 150mg/m2/tri-week S-1 40-60mg/twice/day(day1-15)/tri-week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically proven colorectal cancer (Adenocarcinoma) 2.Unresectable advanced/recurrent colorectal cancer 3. A measurable lesions in RECIST criteria is unnecessary 4. Metastatic colorectal cancer refractory to S-1, oxaliplatin, and Bmab therapy as first-line 5. Chemotherapy without 2 weeks before the initial administration of the study drug 6. Previously not treated radiotherapy for unresectable colorectal cancer 7. Aged 20-80 years at the time of registration 8. Performance status(ECOG) :0,1 9.Life expectancy estimated>=3 months 10.Adequate organ function 11. No abnormally electrocardiogram 12. Written IC 13. Able to receive oral treatment

Exclusion criteria

Exclusion criteria: 1. History of serious drug hypersensitivity 2. Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant. 3. Active infections 4. 4. Serious complications 5. Peptic ulcers 6. Over grade 2 diarrhea 7. Massive pleural effusion or ascites 8. Mechanical bowel obstruction 9. Symptomatic peritoneum dissemination 10. Brain metastasis 11. Current or previous (within the last 6 months) history of GI perforation 12. Hemoptysis 13. Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia 14. Evidence of bleeding diathesis or coagulopathy 15. Ongoing treatment with anticoagulant or aspirin (> 325mg/day) 16. Administering transfusion within 14 days 17. Other active malignancies 18. Administration contraindication of 5-FU(Capecitabine, TS-1) Oxaliplatin, CPT-11 and Bevacizumab 19. Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Response rate (RR) Time to treatment failure (TTF) Overall Survival (OS) Safety profile Relative dose intensity(RDI)	—

Countries

Japan

Contacts

Public ContactSoichi Tsutsumi

Gunma University Graduate School Department of General Surgical Science

chuchumi@gunma-u.ac.jp027-220-8224

Outcome results

None listed

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