A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.

A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go. - A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022535

Enrollment

Registered

2016-05-31

Start date

2015-05-30

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

unresectable colorectal cancer

Interventions

TAS-102+Bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with unresectable advanced/relapsed colorectal cancer. 2. Aged over 20 at the time of informed consent. 3. ECOG performance status (PS) of 0 to 2 4. Patients with lesion(s) that can be evaluated and it should be confirmed by CT, MRI, X-ray. 5. The cases without a history of chemotherapy but possible to register if over 180 days have been passed since the last day of postoperative adjuvant chemotherapy. 6. Oral intake 7. Major organ functions are maintained by a laboratory study. 8. The cases could survive at least for 3 months from the registration day. 9. IC is obtained in a document from the patients.

Exclusion criteria

Exclusion criteria: 1. The cases with serious drug hypersensitivity or allergy. 2. Pregnant or men who expect the partner's pregnancy. 3. The cases with infectious disease requiring systemic therapy. 4. The cases with serious complications - Interstitial pneumonia, pulmonary fibrosis - Heart failure - Renal failure - Liver failure - Poor control diabetes mellitus - Poor control high blood pressure 5. Cases with ECG abnormalities are found or heart disease as a clinical problem , ( heart failure , myocardial infarction , angina pectoris). 6. Cases with gastrointestinal ulceration or bleeding. 7. Pre-existing with hemoptysis. 8. Cases with peripheral nerve disorder. 9. Patients who need a treatment for abdominal dropsy and pleural effusion. 10. Possibility of brain metastasis. 11. Perforation of the digestive tract within 6 months from the day of registration. 12. Pre-existing with thromboembolism, cerebral infarction, lung infarction and pneumonitis. 13. Surgery within 28 days from the registration day. 14. Bleeding tendency 15. Multiple primary cancers 16. Constitutional administration therapy with steroid 17. The cases judged to be unsuitable for registration. 18. Primary lesion with stricture 19. Cases with peritoneal metastasis

Design outcomes

Primary

Measure	Time frame
PFS: Progression-free survival	—

Countries

Japan

Contacts

Public ContactKyoichi Kaira

Gunma University Graduate School of Medicine Department of Oncology Clinical Development

kkaira1970@yahoo.co.jp027-220-8222

Outcome results

None listed

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