Skip to content

Randomized pahse III study evaluating the efficacy of hepatic arterial infusion chemotherapy for metastatic colorectal cancer patients with unresectable liver metastases

Randomized pahse III study evaluating the efficacy of hepatic arterial infusion chemotherapy for metastatic colorectal cancer patients with unresectable liver metastases - JIVROSG-0606(HAIC Phase III)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001491
Enrollment
150
Registered
2008-11-10
Start date
2008-11-01
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 cancer

Interventions

In the tested group, after the radiological placement of port and catheter system, hepatic arterial infusion using 5FU is performed within 6 months at the longest, and then FOLFOX+Bevacizumab therapy

Sponsors

Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)pathologically confirmed colorectal cancer 2)ALP more than 600 IU/L and unresectable liver metastases 3)No prior treatment using L-OHP or Bevacizumab 4)20 years old or more 5)Performance status (ECOG):0-2 6)No mtter of measurable lesion 7)Previous chemotherapy as folloes; - No prior chemotherapy - Chemotherapy of fluoropyrimidines for less than 2 weeks - Previous adjuvant chemotherapy of fluoropyrimidines with more than 6 months interval to the recurrence, and no previous chemotherapy to the recurrence 8)Within normal function of major organs 9)More than 8 weeks survival expected 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Massive pleural effusion or ascites 2)Bleeding of digestive organ 3)Uncontrolled active infection 4)Severe complications (ileus, interstitial pneumonia, uncontrolled-diabetis, cardiac failure, renal failure, liver cirrhosis, liver failure- 5)Active other malignancy 6)Phsicological disorder 7)Pregnancy or lactation 8)Positive HBs 9)Severe allergy to iodine contrast medium 10)Bone metastases requiring local treatment 11)Brain metastasis or suspiciou brain metastasis 12)Thrombosis or Embolism within 1 year 13)Grade 2 or more sensory disturbance (CTCAEv3.0) 14)Requiring anti-thrombogenic therapy to prevent thrombosis 15)Unsuitable by physician's decision

Design outcomes

Primary

MeasureTime frame
Overall survival period

Secondary

MeasureTime frame
Adverse events Time to treatment failure

Countries

Japan

Contacts

Public ContactTakashi Ura

Aichi Cancer Center Hospital Department of Medical oncology

tura@aichi-cc.jp052-762-6111

Outcome results

None listed

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