Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases

Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases - Phase II trial of Bevacizumab with XELOX as an adjuvant treatment after resection of colorectal liver metastases (Miyagi-HBPCOG 007)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004352

Enrollment

Registered

2010-10-10

Start date

2010-11-01

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

Colorectal liver metastases

Interventions

After resection of colorectal liver metastases, chemotherapy with bevacizumab plus XELOX repeats every 3 weeks for 8 times.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed colorectal carcinoma 2.Curative resection (sR0, sR1) for synchronous or metachronous liver metastases and primary tumour. No prior radiotherapy for liver metastases 3.No extrahepatic metastases or recurrence 4.Expect first administration within 4~8 weeks after liver resection (Enrollment is within 2~8 weeks after liver resection) 5.Age >=20 years 6.ECOG PS 0-1 7.Needs adequate organ function 8.Witten informed consent

Exclusion criteria

Exclusion criteria: 1. Recurrence of chemotherapy of capecitabine, oxaliplatin and bevacizumab less than 6 months 2. Active multiple cancers (within 5 years) 3. Histry of hyper sensitivity against bevacizumab, oxaliplatin and capecitabine 4. Serious infections 5. Serious complications 6. Serious alteration or paresthesia interfering with function 7. Pregnancy woman, or woman with suspected pregnancy 8. Histry of organ recipient 9. Surgery, biopsy, specimen with section or sutures within the past 2 weeks. Fine needle aspiration biopsy within 1 week 10. Thrombosis with present or history of thromboembolism within the past 1 year 11. Administrated with Aspirin (>=325mg/day) or steroid for RA and chronic inflammatory disease 12. Untreatment of traumatic bone fracture 13. Require treatment of renal dysfunction, or urine protein >+2 within 2 weeks 14. Uncontrollable hypertension 15. Uncontrollable diarrhea 16. Uncontrollable peptic ulcer disease 17. Severe pulmonary disease (Interstitial pneumonitis or pulmonary fibrosis) 18. Cardiac disease (over grade2 by CTCAE v4.0).Or histry of myocardial infarction within 1 year 19. Doubting dihydropyrimidine dehydrogenase (DPD) deficit 20. Any subject judged by the investigator to be unfit for any reason to participate in the study

Design outcomes

Primary

Measure	Time frame
disease free survival	—

Secondary

Measure	Time frame
Overall survival 2-year DFS rates Relapse-free survival Safety Treatment continuation rate 5 courses 8 courses	—

Countries

Japan

Contacts

Public ContactKei Nakagawa

Tohoku University Graduate School of Medicine Division of Integrated Surgery and Oncology

kein_h11@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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