Liver cancer radiation trial halted after just one patient

NCT ID NCT02200042

Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study aimed to see if adding focused radiation to standard chemotherapy helps people with a type of liver cancer (intrahepatic cholangiocarcinoma) that cannot be removed by surgery. Only one person enrolled before the trial was stopped early, so no meaningful conclusions can be drawn. The approach combined image-guided radiation with gemcitabine and cisplatin drugs.

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 (image-guided radiation therapy)
What this could lead to: If successful, this could show that adding radiation to chemotherapy improves survival for people with liver cancer that cannot be surgically removed.
What could go wrong: The trial was terminated after enrolling only 1 person, so it cannot provide reliable evidence. It is unclear if radiation adds benefit or increases side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1 person

The number who actually took part.

Started

Sep 2014

Finished

Jul 2018

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

18 years and older

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Pathologically (histologically or cytologically) proven diagnosis of intrahepatic cholangiocarcinoma (IHC) without distant extrahepatic metastasis prior to study entry. Patients with an adenocarcinoma suggestive of a pancreaticobiliary primary with radiographic findings consistent with an intrahepatic cholangio-carcinoma are eligible. 2. Patient must have 1 lesion with a maximum AXIAL diameter of 12cm at the time of study entry. Up to 3 satellite lesions are permitted. Satellite lesions, are defined as lesions less than 2 cm that are within 1 cm of the periphery of the dominant lesion (gross tumor volume \[GTV\]) are permitted. The satellite lesions are NOT included in the AXIAL diameter measurement. Regional Lymph Node involvement within the porta hepatis (as medial as superior mesenteric vein \[SMV\] portal vein confluence) is permitted if nodes are deemed clinically positive (i.e. FDG \[Fluorine 18 fluorodeoxyglucose\] avid); 3. Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: • Pre-study entry Scan (REQUIRED for All Patients to confirm no progression): computed tomography (CT) scan chest/abdomen/pelvis with multiphasic liver CT scan within 30 days prior to study entry. If CT contrast is contraindicated, CT chest without contrast and MRI of abdomen and pelvis is permitted; 4. Zubrod Performance Status 0-1 at the time of study entry; 5. Age ≥ 18; 6. Complete blood count (CBC) / differential obtained within 21 days prior to study entry, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3; * Platelets ≥ 75,000 cells/mm3; * Total bilirubin \< 2.5 mg/dl; * Aspartate Aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase \[SGPT\]) \< 5.0 X institutional upper limit of normal; * Albumin ≥ 2.5mg/dl; * Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for subject with creatinine levels above institutional normal; * Hemoglobin(Hgb) ≥ 9.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 9.0 g/dl is acceptable.) 7. Patient must provide study specific informed consent prior to study entry; 8. Negative Beta-Human Chorionic Gonadotropin (bHCG) prior to study entry if patient is pre or peri-menopausal. 9. Must have received 6 months of Gemcitabine/Cisplatin chemotherapy without progression. Disease response to chemotherapy is also permitted. If toxicity precludes 6 months of chemotherapy at least 4 months of Gemcitabine/Cisplatin must have been administered. Exclusion Criteria: 1. Multiple lesions that don't meet the criteria as satellite lesions as defined in protocol; 2. Extrahepatic metastases or malignant nodes beyond the periportal region. Celiac, pancreaticoduodenal and para-aortic nodes\> 2 cm are ineligible. Note that benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is \> 2.0 cm; 3. Hepatic insufficiency resulting in clinical jaundice, encephalopathy and/or variceal bleed at the time of study entry; 4. Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields; 5. Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time; 6. Direct tumor extension into the stomach, duodenum, small bowel or large bowel; 7. Prior invasive malignancy, excluding the current diagnosis, (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (Note: carcinoma in situ of the breast, oral cavity, or cervix is all permissible); 8. Prior systemic chemotherapy for the study cancer other than gemcitabine/cisplatin; note that prior chemotherapy for a different cancer is allowable; 9. Currently receiving other anti-cancer agents; 10. Participants who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin; 11. Prior surgery for the IHC. (Liver resection is not allowed); 12. Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months of study entry; * Transmural myocardial infarction within the last 6 months of study entry; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry; * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to study entry; * HIV positive with CD4 (cluster of differentiation 4) count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter at the time of study entry. Note also that HIV testing is not required for eligibility for this protocol; * End-stage renal disease (ie, on dialysis or dialysis has been recommended). 13. Pregnancy 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 involved in this study may be significantly teratogenic; 14. Grade 3 or higher peripheral neuropathy at the time of study entry.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage III intrahepatic cholangiocarcinoma Stage IVA intrahepatic cholangiocarcinoma

Contacts and locations

Locations

Boston Medical Center

Boston, Massachusetts, 02118, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
FHCC Proton Therapy Center

Seattle, Washington, 98133, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States
Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Mount Sinai Hospital

New York, New York, 10029, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern University

Chicago, Illinois, 60611, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Sutter Medical Center Sacramento

Sacramento, California, 95816, United States
The Research Institute of the McGill University Health Centre (MUHC)

Montreal, Quebec, H3H 2R9, Canada
UT MD Anderson Cancer Center

Houston, Texas, 77030, United States
University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Rochester

Rochester, New York, 14642, United States
University of Vermont Medical Center

Burlington, Vermont, 05401, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States