New radiation approach aims to treat liver tumors in patients with damaged livers
NCT ID NCT02626312
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase I trial tested radiation therapy in 36 patients with liver cancers (hepatocellular carcinoma, cholangiocarcinoma, or metastases) who also have impaired liver function from cirrhosis, chemotherapy, or surgery. The goal was to find the safest dose and understand side effects. The study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy
- What this could lead to
- If successful, this could help determine safe radiation doses for liver cancer patients with poor liver function, potentially improving tumor control.
- What could go wrong
- This is an early phase I trial with only 36 participants, terminated early, so results are limited. The focus is on safety, not effectiveness, and liver damage may still occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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36 people
The number who actually took part.
- Started
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Feb 2016
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of hepatocellular carcinoma, cholangiocarcinoma, or liver metastasis from any histology * Patients may have single or multinodular tumors * There is no specific tumor size cut-off for this protocol; however, the radiation treatment plan must meet the protocol's dose constraints * Compromised liver function as defined by any of the following: * Cohort 1: Advanced cirrhosis group * Borderline Child-Pugh class A6 * Child-Pugh class B * The patients in this advanced cirrhosis group must have at least 400 ml of functional liver, as estimated on either diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) or single photon emission computed tomography (SPECT)/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients * Cohort 2: Low functional liver volume without underlying chronic liver disease * Previous irinotecan or oxaliplatin chemotherapy * Previous liver resection(s) * These patients must have at least 400 ml of functional liver, as estimated by either diagnostic imaging computed tomography or magnetic resonance imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients; * Cohort 3: History of prior liver-directed radiation therapy with either fractionated external beam radiation therapy (EBRT), stereotactic body radiation therapy (SBRT) or yttrium-90 radioembolization (Y90 RE); the interval between prior EBRT and re-irradiation on protocol should be equal to or greater than 12 months; the interval between prior Y90 RE and re-irradiation on protocol should be equal to or greater than 6 months; * Cirrhosis group: * Child-Pugh class A5; * Borderline Child-Pugh class A6; * The patients in this group must have at least 400 ml of functional liver, as estimated on either diagnostic imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients * Low functional liver volume without underlying liver disease * Previous irinotecan or oxaliplatin chemotherapy * Previous liver resection(s) * These patients must have at least 400 ml of functional liver, as estimated by either diagnostic imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding * Prior history of surgical resection, chemotherapy, transarterial chemoembolization (TACE), and/or radiofrequency ablation are allowed * Expected survival must be greater than 3 months * Patients may receive concurrent capecitabine or sorafenib at the discretion of the treating physicians * Signed study-specific consent form Exclusion Criteria: * Prior liver-directed radiation therapy in cohort 1 (advanced cirrhosis group) or cohort 2 (low functional volume group) * Prior yttrium-90 therapy for patients in cohorts 1 or 2 * Patients with a Child-Pugh score less than 6 or greater than 9 for radiation naive patients with cirrhosis (cohort 1) * Child-Pugh score of greater than 6 for patients with cirrhosis who previously received liver directed radiation (EBRT or Y90 RE) (cohort 3) * Unstable angina and/or symptomatic congestive heart failure requiring hospitalization within the last 6 months; transmural myocardial infarction within the last 6 months prior to study entry * Current evidence of fever or untreated infection * Active hepatitis, including but not limited to viral and drug-induced * Poorly controlled inflammatory bowel disease * Women with a positive pregnancy test * Inability to comply with study and/or follow-up procedures * Patients with an active second malignancy or prior invasive malignancy unless disease free for a minimum of 3 years; non-melanoma skin cancer and previous early prostate cancer that had a non-rising prostate-specific antigen (PSA) can be enrolled
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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