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CholangiocarcinomaPhase 1NCT02626312

Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function

A Phase 1 study testing Laboratory Biomarker Analysis, Magnetic Resonance Imaging and Radiation Therapy in people with Cholangiocarcinoma and Cirrhosis, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial studies the side effects and the best dose of radiation therapy in treating patients with hepatocellular carcinoma, cholangiocarcinoma, or cancer that has spread from the original (primary) tumor to the liver who also have impaired liver function (liver damage caused by cirrhosis, chemotherapy, or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Magnetic Resonance Imaging and Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
15 Feb 2016to 10 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Phase I Trial of Radiation Therapy in Patients With Liver Cancers and Impaired Liver Function

This phase I trial studies the side effects and the best dose of radiation therapy in treating patients with hepatocellular carcinoma, cholangiocarcinoma, or cancer that has spread from the original (primary) tumor to the liver who also have impaired liver function (liver damage caused by cirrhosis, chemotherapy, or surgery). Radiation therapy (RT) uses high energy x-rays to kill tumor cells and shrink tumors. New methods of giving RT to the liver may help control cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety of high dose radiotherapy in patients who have liver tumors (hepatocellular carcinoma [HCC]/cholangiocarcinoma/liver metastases from any primary) and who have impaired liver function or low functional liver volume or who have received prior liver radiation.

SECONDARY OBJECTIVES:

  1. To evaluate 2 year local control with radiotherapy in these patients. II. To evaluate tumor response, patterns of failure, and survival in these patients.

III. To evaluate imaging- and serum-based biomarkers in these patients, as correlates of hepatic toxicity and tumor response.

OUTLINE: This is a dose-escalation study.

Patients undergo radiation therapy 5 days a week for a total of 15 or 25 fractions in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4-8 weeks and then every 3-4 months for 2 years. Patients who progress during the two year follow-up period are followed up every 6 months.

Being tested
Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Radiation Therapy, Survey Administration
Medical subject headings
Cholangiocarcinoma, Fibrosis, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan

    Correlative studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation

    Undergo radiation therapy

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT02626312
Study groupRoleWhat they receive
Treatment (radiation therapy)ExperimentalPatients undergo radiation therapy 5 days a week for a total of 15 or 25 fractions in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Radiation: Radiation Therapy; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum dose constraint

    Defined as the highest level dose constraint at which no more than 1 of 6 evaluable patients has had a dose limiting toxicity. Toxicities will be summarized with frequency by type, severity and their relationship to the treatment.

    Measured: 4-8 weeks after completion of radiation therapy

Secondary outcomes (4)

  1. Local disease control rate

    The Kaplan Meier method will be used to estimate 2-year local disease control rate.

    Measured: Up to 2 years

  2. Tumor response

    Will be observed.

    Measured: Up to 2 years

  3. Patterns of failure

    Will be observed.

    Measured: Up to 2 years

  4. Overall survival

    The Kaplan Meier method will be used to estimate the probability of overall survival.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study start15 Feb 2016
  3. Primary completion10 Jun 2026
  4. Study completion10 Jun 2026

Why it stopped: \< 75% participation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02626312
Sponsor's protocol ID
2015-0052
Other IDs
P30CA016672, NCI-2016-00006, 2015-0052
Status last verified
Jun 2026
First submitted
7 Dec 2015
Last updated
17 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Chang E, Holliday EB, Szklaruk J, Erwin WD, Ludmir EB, Noticewala SS, Das P, Koong AC, Minsky BD, Smith GL, Sawakuchi GO, Martin-Paulpeter RM, Niedzielski JS, Perles LA, Beddar S, Valino VS, Nguyen JL, Raghav KPS, Javle M, Kaseb AO, Dasari AN, Overman MJ, Parseghian CM, Odisio BC, Mahvash A, Kuban JD, Shen SE, Wang XS, Gupta AC, Al Taie MM, Brock KK, Tzeng CD, Vauthey JN, Wong FCL, Koay EJ. Single-photon emission computed tomography functional liver imaging to facilitate reirradiation for liver malignancies: A phase I trial. JHEP Rep. 2026 Apr;8(4):101743. doi: 10.1016/j.jhepr.2026.101743. Epub 2026 Jan 22.

    PubMed 41825097

  • Chang E, Wong FCL, Chasen BA, Erwin WD, Das P, Holliday EB, Koong AC, Ludmir EB, Minsky BD, Noticewala SS, Smith GL, Taniguchi CM, Rodriguez MJ, Beddar S, Martin-Paulpeter RM, Niedzielski JS, Sawakuchi GO, Schueler E, Perles LA, Xiao L, Szklaruk J, Park PC, Dasari AN, Kaseb AO, Kee BK, Lee SS, Overman MJ, Willis JA, Wolff RA, Tzeng CD, Vauthey JN, Koay EJ. Phase I trial of single-photon emission computed tomography-guided liver-directed radiotherapy for patients with low functional liver volume. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae037. doi: 10.1093/jncics/pkae037.

    PubMed 38730548

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis, Magnetic Resonance Imaging and Radiation Therapy in people with Cholangiocarcinoma and Cirrhosis, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: \< 75% participation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum dose constraint (time frame: 4-8 weeks after completion of radiation therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02626312, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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