Clinical trial for Hepatocellular Carcinoma (HCC)
Official title Hyperpolarized 13C-MRI in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy, Atezolizumab, and Bevacizumab
ClinicalTrials.gov ID: NCT06605664
What this study is testing
- What it's testing
- Increased pyruvate-to-lactate conversion is a hallmark of HCC metabolism.
- Phase 2: a mid-size study of how well it works
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
- Histologically or cytologically proven diagnosis of HCC.
- Typical arterial enhancement and delayed washout on multiphasic CT or MRI.
- Age ≥18 years at the time of signing informed consent document.
- ECOG performance status 0-1.
- Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C).
You likely can't join if
- Prior invasive malignancy unless disease free for a minimum of 2 years
- Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
- Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
- Untreated active hepatitis B or hepatitis C
- Moderate to severe or intractable ascites
- Presence of distant metastases
See the full eligibility criteria
- Histologically or cytologically proven diagnosis of HCC.
- Typical arterial enhancement and delayed washout on multiphasic CT or MRI.
- Age ≥18 years at the time of signing informed consent document.
- ECOG performance status 0-1.
- Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C).
- Child-Pugh score 5-6 liver function within 28 days of study registration.
- Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.
- Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.
- Ability to understand and the willingness to sign a written informed consent document
- Adequate bone marrow, liver, and renal function within 4 weeks before study registration
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1,000/mm3
- Platelet count ≥ 50,000/μL
- Total bilirubin \< 2.5 mg/dL
- Serum albumin \>2.8 g/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN)
- Prothrombin time ≤ 6 seconds prolonged
- Serum creatinine ≤ 1.5 mg/dL
- The medical team, experienced in liver cancer treatment, has evaluated and confirmed that the benefits outweigh the risks for participants receiving proton or photon radiation therapy combined with atezolizumab and...
- Prior invasive malignancy unless disease free for a minimum of 2 years
- Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
- Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
- Untreated active hepatitis B or hepatitis C
- Moderate to severe or intractable ascites
- Presence of distant metastases
- Untreated or incomplete treated esophageal or gastric varices
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
- Myocardial infarction within the last 6 months prior to study entry
- Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry
- A bleeding episode within 6 months prior to study entry due to any cause.
- Thrombolytic therapy within 28 days prior to study entry.
- Known bleeding or clotting disorder.
- Uncontrolled psychotic disorder
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Prior solid organ transplantation.
- Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener...
- Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.
- Inability to treat all sites of disease by proton radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints cannot be met for covering all sites of liver tumors using...
- Known HIV infection.
- Conditions not suitable for magnetic resonance imaging (MRI) include the presence of strongly magnetic arterial clips in the brain, cardiac pacemakers, cochlear implants, and claustrophobia.
- Concurrent medical conditions that may impact patients during MRI examination include active infections, symptomatic congestive heart failure, uncontrollable angina, arrhythmias, mental disorders, difficulty breathing...
- An endoscopy report within the past six months indicates a high risk for upper gastrointestinal bleeding, and the patient has not received complete treatment for its prevention.
- Individuals who are allergic to hyperpolarized 13C pyruvate, atezolizumab, bevacizumab, or any ingredients contained in these medications.
The study team makes the final eligibility decision.
Where it is enrolling
- Taoyuan City, Taiwan, Taiwan
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, but 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?
This study is enrolling now at Taoyuan City, Taiwan, Taiwan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.