Unresectable Colorectal Liver Metastasis Clinical Trial
Official title:
A Prospective Open-label Study of Transarterial Chemoembolization by Hepasphere Microspheres for the Treatment of Unresectable Colorectal Liver Metastasis
| Verified date | June 2019 |
| Source | National Taiwan University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause
of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year
approximately 60% will develop liver metastasis during the course of their disease. In
approximately 30% of these patients who develop liver metastasis the metastatic disease will
remain confined to the liver.
For the 70-75% of colorectal patients with colorectal liver metastasis not suitable for
hepatic resection or similarly ablative therapy with curative intent, systemic chemotherapy
is the standard initial management. However, after a patient has failed first- line and in
some cases second-line chemotherapy, response rates fall to as low as 12% (Chen HX 2006).
Transarterial chemoembolization (TACE) with microsphere is an alternative treatment because
normal liver tissue receives most of its blood supply from the portal vein, while colorectal
liver metastases derive most of their flow from the hepatic artery. Several clinical trials
have explored the feasibility and the efficacy of TACE with microsphere as a treatment for
patients with colorectal liver metastasis. HepaSphere represents a novel drug delivery system
for chemoembolization, which can add two benefits to embolization therapy. First, by
ionically binding the doxorubicin throughout the microspheres, more drug can be delivered
into the tumor, with less escape into peripheral circulation. Second, conformability to the
architecture of the vessel lumen, providing more contact surface area with the embolic
material and the vessel intima, leading to a more complete occlusion. However, there are
limited experiences in using HepaSphere TACE for colorectal liver metastasis in Taiwan. In
this pilot study, we will evaluate the initiate safety and efficacy of Hepasphere
microspheres loaded with a chemotherapeutic agent doxorubicin for the treatment of patients
who have failed first-line and second-line systemic chemotherapy.
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | September 11, 2018 |
| Est. primary completion date | January 26, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Patients must meet all of the following inclusion criteria in order to be entered into the study: 1. Liver dominant metastatic colorectal cancer 2. Metastatic colorectal patients who have failed first-line and second-line systemic chemotherapy. 3. ECOG 0 to 1 or a Karnofsky Performance score of 80-100%; 4. Age 20 years or older 5. Patient has signed informed consent Exclusion Criteria: - If patients meet any of the following criteria they may not be entered into the study: 1. History of severe allergy or intolerance to any contrast media not controlled with premedication 2. Severe peripheral vascular disease that would preclude catheterization 3. Significant extra-hepatic disease, generally in excess of 50% of the overall whole body tumor bulk outside the liver, or any tumor burden that represented an imminent threat to the patient's life 4. Greater than 75% hepatic parenchymal involvement. Previous treatment with any form of transarterial embolization for liver tumors f. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive g. Any contraindication to arteriography or hepatic embolization |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hepatic Progression free survival | To define all participants from the day of the first HepaSphere Tx until the date that hepatic progression or death is first reported, whichever comes first. | up to one year | |
| Secondary | An overall tumor response classification | The tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis, and includes assessment of viable tumor, which is defined as uptake of contrast agent in the arterial phase of computed tomography (CT). | up to one year |