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Compares treatment options for Hepatocellular Carcinoma
Official title Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Liver Carcinoma
ClinicalTrials.gov ID: NCT03895359
What this study is testing
What is Transarterial Chemoembolization?
Transarterial Chemoembolization is an investigational medicine, given as an once-daily, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as TACE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Trans-arterial chemoembolization (TACE) is a standard treatment for patients with hepatocellular carcinoma (also called liver cancer). This is where chemotherapy is injected into the arteries of the liver and liver cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Primary hepatobiliary cancer confirmed pathologically
- Non - lymphoma liver metastases confirmed pathologically
- Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non - lymphoma cancer and a previously...
- Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the...
- ≤ 5 liver lesions measurable on a contrast - enhanced liver CT or MRI performed within 90 days prior to study entry.
You likely can't join if
- Severe cirrhosis or liver failure defined as Child Pugh \> B7
- Primary liver tumor or liver metastasis \> 25 cm in maximal dimension.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity, defined as limiting the patients life to less than 6 months
- Active hepatitis or clinically significant liver failure.
- Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms...
See the full eligibility criteria
- Primary hepatobiliary cancer confirmed pathologically
- Non - lymphoma liver metastases confirmed pathologically
- Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non - lymphoma cancer and a previously negative CT or MRI of the liver
- Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the setting of cirrhosis or chronic hepatitis.
- ≤ 5 liver lesions measurable on a contrast - enhanced liver CT or MRI performed within 90 days prior to study entry.
- Primary liver lesion or liver metastases measuring ≤ 25 cm.
- Extrahepatic cancer is permitted if liver involvement is judged to be life - limiting.
- All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria.
- Patient must be judged medically or surgically unresectable
- Zubrod Performance Scale = 0 - 3
- Age \> 18
- All intrahepatic disease must be amenable to TACE
- Previous liver resection or ablative therapy is permitted.
- Chemotherapy must be completed at least 2 weeks prior to radiation therapy or TACE, and not planned to be administered for at least 1 week (for anthracyclines at least 4 weeks) after completion of treatment.
- Life expectancy \> 6 months.
- Women of childbearing potential and male participants must practice adequate contraception.
- Patient must sign study specific informed consent prior to study entry. Pretreatment Evaluations Required for Eligibility:
- A complete history and general physical examination.
- CBC, INR, Total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry. Appropriate levels are as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells / mm3
- Platelets ≥ 70,000 cells / mm3
- Hemoglobin ≥ 8.0 g / dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g / dl is acceptable.)
- Total bilirubin \< 3 mg / dL
- Prothrombin time / INR \< 2 (if not on anticoagulants)
- Albumin ≥ 28 g / L
- AST and ALT \< 10 times ULN
- Severe cirrhosis or liver failure defined as Child Pugh \> B7
- Primary liver tumor or liver metastasis \> 25 cm in maximal dimension.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity, defined as limiting the patients life to less than 6 months
- Active hepatitis or clinically significant liver failure.
- Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment...
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.