Irinotecan -Eluting LC Bead-M1 (DEBIRI-M1) for Patients With Liver Metastases From Colorectal Cancer

Inclusion Criteria:

-Patients with a diagnosis of colorectal cancer with hepatic metastases who have failed or
are intolerant to at least one systemic chemotherapy or liver directed therapy.

1. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
at study entry.

2. The patient is age 18 years or older.

3. The patient has a life expectancy of >12 weeks.

4. Patients with liver dominant disease defined as >/=75% tumor body burden confined to
the liver

5. Less than 60% liver tumor replacement

6. At least one month has elapsed since most recent prior cancer therapy with the
following exception:

-Chemotherapy (excluding irinotecan based regimens) may continue if there is evidence
of hepatic progression on treatment providing there is no change in the therapy in the
1 month prior to DEBIRI-TACE treatment and any immediate chemotherapeutic toxicity
that will complicate DEBIRI-TACE is resolved. In this case, the chemotherapy may
continue because it is continuing to control the extrahepatic disease.

7. The patient has measurable disease that will be directly treated with intrahepatic
therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

8. Patients with at least one measurable liver metastases> 2 cm.

9. Patients with patent main portal vein

10. The patient has adequate hematologic function as defined by the following criteria:

-An absolute neutrophil count (ANC) >/= 1500/mL, Hemoglobin >/= 9.5 g/dL, and a
Platelet count >/=75,000/mL, INR
11. The patient has adequate hepatic function, as defined by the following criteria:

-Total bilirubin (ALT) 2.

12. The patient has adequate renal function, as defined by the following criteria:

-Serum creatinine
13. The patient has a baseline international normalized ratio (INR)<1.5.

14. The patient, if a woman of childbearing potential, has a negative pregnancy test.

15. The patient is able to give written informed consent.

16. The patient is willing and able to comply with study procedures, scheduled visits, and
treatment plans.

Exclusion Criteria:

1. The patient has a history of another primary cancer (ie, a primary cancer not
associated with the patient's current liver tumor), with the exception of (a)
curatively resected nonmelanomatous skin cancer; (b) curatively treated cervical
carcinoma in situ; or (c) other primary solid tumor treated with curative intent, no
known active disease present, and no treatment administered during the last 3 years
prior to enrollment (date of informed consent).

2. Any contraindication for hepatic embolization procedures:

- Large shunt as determined by the investigator (pretesting with TcMMA not
required)

- Severe atheromatosis

- Hepatofugal blood flow

- Main portal vein occlusion (e.g. thrombus or tumor)

- Any patient eligible for curative treatment (i.e. resection or radiofrequency
ablation)

- Patients' whose only measurable disease is within an area of the liver previously
subject to radiotherapy

3. Contraindications to irinotecan:

- Chronic inflammatory bowel disease and/or bowel obstruction

- History of severe hypersensitivity reactions to irinotecan hydrochloride
trihydrate, lactic acid or to any of the excipients of Camptosar

- Severe bone marrow failure

- History of Gilbert Syndrome (specific testing not required)

- Concomitant use with St John's Wort (Hypericum)

- Marco-shunting noted on the hepatic angiogram.

4. The patient has untreatable bleeding diathesis.

5. The patient has complete main portal vein thrombosis with reversal of flow.

6. The patient has evidence of clinically significant peripheral vascular disease.

7. The patient has brain metastases

8. The patient has clinically significant or symptomatic extrahepatic disease, for
example, an uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection requiring parenteral antibiotics

- Symptomatic congestive heart failure (class II to IV of the New York Heart
Association classification for heart disease)

- Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within
6 months

- Uncontrolled hypertension (systolic blood pressure>150 mmHg, diastolic blood
pressure>90 mmHg, found on 2 consecutive measurements separated by a 1-week
period despite adequate medical support)

- Clinically significant cardiac arrhythmia (multifocal premature ventricular
contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or
requires treatment [NCI-CTCAE Grade 3] or asymptomatic sustained ventricular
tachycardia)

9. The patient is pregnant or breast-feeding.

10. Psychiatric illness/social situations that would compromise patient safety or limit
compliance with study requirements

11. There is evidence of substance abuse or medical, psychological or social conditions
that may interfere with the patient's participation in the study or evaluation of
study results

12. The patient is allergic to contrast media that cannot be readily prevented with
premedication or managed.

13. Other significant medical or surgical condition, or any medication or treatment, that
would place the patient at undue risk and that would preclude the safe use of
chemoembolization or would interfere with study participation

14. The patient has peritoneal disease or ascites (greater than trace on imaging).