Safety and efficacy of preoperative chemotherapy with mFOLFOX6+Bevacizumab in patients with liver-only metastases (H2, H3) from colorectal cancer; histological assessment of liver damage from preoperative chemotherapy.

Safety and efficacy of preoperative chemotherapy with mFOLFOX6+Bevacizumab in patients with liver-only metastases (H2, H3) from colorectal cancer; histological assessment of liver damage from preoperative chemotherapy. - Safety and efficacy of preoperative chemotherapy with mFOLFOX6+Bevacizumab in patients with liver-only metastases (H2, H3) from colorectal cancer; histological assessment of liver damage from preoperative chemotherapy.(KSCC0802)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001308

Enrollment

Registered

2008-08-08

Start date

2008-06-17

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

Patients with liver-only metastases from colorectal cancer

Interventions

mFOLFOX6+Bevacizumab was administered for six cycles, but sixth cycle of therapy did not include Bevacizumab. Surgery was planned 2 weeks after the last dose of chemotherapy, resulting in a gap of 6-9

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. colorectal cancer, cytologically and/or histrogically 2. with measurable lesions in the live only (no extrahepatic disease) 3. degree of liver metastases: H2, H3 4. no prior chemotherapy 5. no prior radiotherapy 6. age: 20-75 years old 7. Performance status(ECOG):0, 1 8. Life expectancy estimated >= 3 months 9. Sufficient organ functions 10. written informed consents

Exclusion criteria

Exclusion criteria: 1. Administering antithrobotic drug within 7 days 2. Serious drug hypersensitivity or a history of drug allergy 3. Peripheral neuropathy 4. Active concomitant malignancy 5. Active infections 6. Serious complications (renal failure or hepatic failure) 7. High blood pressure and diabetic and hypercalcemia that cannot be controlled 8. symptomatic or asymptomatic but treated heart disease 9. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 10. histry of mental disturbances or cerebrovascular attack 11. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 12. Current or previous (within one year) history of GI perforation 13. Plerral effusion, peritoneal fluid and pericardial fluid 14. Symptomatic brain metastasis 15. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 16. under coutinuous steroid therapy 17. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 18. CV-port procedure within one week 19. Anti-platelets therapy (including aspirin and NSAIDS) 20. Bleeding tendency, coagulation abnormality 21. history of organ transplantation 22. Traumatic gracture of unrecovery 23. Bevacizumab used previous chemotherapy 24. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 25. Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Liver resection rate	—

Countries

Japan

Contacts

Public ContactClinical Research Support Center Kyushu

CReS kyushu KSCC

kscc2@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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