A Multicenter, Open-label Study for E7040 in Japanese Subjects With Hypervascular Tumor and Subjects With Arteriovenous Malformation
Inclusion Criteria
Inclusion criteria:
1. Subjects who are subject to any of the following vascular embolization therapies
1. Subjects with hepatocellular carcinoma (HCC) who have deep stained early stage tumor
confirmed by dynamic computerized tomography (CT) after bolus intravenous infusion of
contrast media and have a typical finding of hypervascular tumor, and are not
amenable to resection and local therapy, and meet any of the following (a) to (c).
1. 1 lesion of > 50 mm in diameter
2. 2 or 3 lesions of > 30 mm in at least one diameter
3. 4 or more lesions
2. Metastatic hepatic cancer Subjects with metastatic hepatic cancer who have deep
stained early stage tumor confirmed by dynamic CT after bolus intravenous infusion of
contrast media and have a typical finding of hypervascular tumor but not amenable to
resection, and whose primary lesion and extrahepatic lesion are controlled.
3. Hypervascular tumor other than metastatic hepatic cancer Subjects with deep stained
early stage tumor confirmed by dynamic CT after bolus injection of contrast media and
who have a typical finding of hypervascular tumor other than the liver (e.g., renal
cell carcinoma, bone soft tissue sarcoma) and meets any of the following (a) to (b).
1. Subjects applicable to pre-operative arterial embolization therapy to reduce
tumor size or volume of bleeding for safer conduct of surgical resection or
local therapy (e.g., radiofrequency ablation (RFA))
2. Subjects in stable general condition and are applicable to pain control
treatment
4. Arteriovenous malformation:
Subjects with arteriovenous malformation (except for central nervous system, heart, and
lung) confirmed by dynamic CT but at a low risk of undesirable reflux into systemic
circulation and with vessel malformation suitable for particle embolization in size
2. Subjects with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 (PS
0-1 for metastatic hepatic cancer)
3. No carry-over effect of prior therapy or adverse drug reactions which may influence the
embolic effect of E7040, if having a history of prior therapy time elapsed from the end of
prior therapy to the start of E7040 embolization therapy should be: Surgery: ≥ 6 weeks
Local therapy: ≥ 4 weeks Embolization for non-target vessel: ≥ 4 weeks
4. With a survival of ≥12 months after the prior arterial embolization therapy using E7040
Exclusion criteria:
1. Subjects with clinical symptom or brain metastasis or cerebral encephalopathy
requiring medical treatment
2. Suspected to have hepatocellular carcinoma (HCC) judging from clinical findings in
patients with any disease other than HCC
3. Previously treated with arterial embolization therapy in target vessel
4. Previously treated with arterial embolization therapy in non-target vessel, resection
in target organ, or local therapy (e.g., RFA) (except for HCC patient)
5. Subjects expected to have artery-pulmonary vein shunt or right-to-left shunt, or
those with a possible risk of influx of embolized particles into the central nervous
system.