Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer

Conversion therapy of Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6 in patients with liver metastatic colorectal cancer - N-SOG 04

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004694

Enrollment

Registered

2010-12-10

Start date

2010-12-01

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

Unresectable colorectal liver metastases

Interventions

Chemotherapy with Cetuximab plus FOLFIRI followed by Bevacizumab plus mFOLFOX6. Treatment repeats every 14 days for up to 12 courses (6 courses for Cetuximab plus FOLFIRI and 6 courses for Bevacizuma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histopathologically confirmed colorectal cancer (2)KRAS wild type(Codon13 and/or 12) (3)Unresectable liver metastases without extrahepatic metastasis or reccurrence (4)No prior chemotherapy with Oxaliplatin,Irinotecan,Bevacizumab and Cetuximab (5)Age: 20 years to 75 years (6)ECOG performance status: 0-1 (7)No severe organ failure and suitable results of all laboratory test a. WBC: >=3,000/mm3 b. Neutrophil count: >=1,500/mm3 c. Platelet count: >=100,000/mm3 d. Hemoglobin: >=8.0g/dL e. Total billilubin: <=2 times the institutional upper limit of normal f. AST and ALT: <=5 times the institutional upper limit of normal g. Serum creatinine: <=2 times the institutional upper limit of normal h. ECG normal or minor abnormality with no-need of treatment (8)A life expectancy of more than 6 month (9)Written informed consent will be obtained from each patient before enrollment

Exclusion criteria

Exclusion criteria: (1)Severe myelosuppression (2)Diarrhea(watery) (3)Require treatment of serious infection (4)Uncontrolled body cavity fluid (5)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (6)Severe hypersensitivity (7)Renal failure or urine protein >=+2 within 1 week before enrollment (8)Uncontrollable hypertension or diabetes (9)Significant abnormal ECG or history of cardiovascular disease within 1year (10)Thrombosis with present or history of thromboembolism within 1year (11)Intestinal bleeding, ileus, bowel obstruction or peptic ulcer (12)Perforation of gastrointestinal tract within 1year (13)Administrated with Aspirin (>=325mg/day) or steroid for rheumatoid arthritis and chronic inflammatory disease (14)Pregnant and lacting woman,woman with suspected pregnancy, and men of the fertility hope (15)Have anti-thrombosis drugs within 7days before enrollment (16)Need to treatment with Atazanavir sulfate (17)Active multiple cancers (18)Severe mental illness (19)Treated continuously with systemic steroids (20)Any subject judged by the investigator to be unfit for any reason to participate in the study

Design outcomes

Primary

Measure	Time frame
Liver resection rate after chemotherapy with Bevacizumab plus mFOLFOX6(R0/R1)	—

Secondary

Measure	Time frame
Liver resection rate(Overall) Liver resection rate after chemotherapy with Cetuximab plus FOLFIRI(R0/R1) Response rate Disease control rate Safety Morbidity	—

Countries

Japan

Contacts

Public ContactKeisuke Uehara

Nagoya University Graduated School of Medicine Division of Surgical Oncology

kuehara@med.nagoya-u.ac.jp052-744-2222

Outcome results

None listed

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