Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function
Phase I Trial of Radiation Therapy in Patients With Liver Cancers and Impaired Liver Function
Sponsor: M.D. Anderson Cancer Center
A observational or N/A phase clinical study on Cholangiocarcinoma and Cirrhosis, this trial is ongoing. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 19 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. 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:
I. 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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Status Flow
Change History
19 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
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Apr 17, 2026 — May 4, 2026 [daily]
Active Not Recruiting
Phase: PHASE1 → None
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Nov 2025 — Apr 2026 [monthly]
Active Not Recruiting PHASE1
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May 2025 — Nov 2025 [monthly]
Active Not Recruiting PHASE1
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Nov 2024 — May 2025 [monthly]
Active Not Recruiting PHASE1
▶ Show 14 earlier versions
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Sep 2024 — Nov 2024 [monthly]
Active Not Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE1
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May 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE1
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Nov 2023 — May 2024 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
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Jun 2023 — Nov 2023 [monthly]
Recruiting PHASE1
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Sep 2021 — Jun 2023 [monthly]
Recruiting PHASE1
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Jan 2021 — Sep 2021 [monthly]
Recruiting PHASE1
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Sep 2019 — Jan 2021 [monthly]
Recruiting PHASE1
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Aug 2019 — Sep 2019 [monthly]
Recruiting PHASE1
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Jun 2019 — Aug 2019 [monthly]
Recruiting PHASE1
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Jun 2018 — Jun 2019 [monthly]
Recruiting PHASE1
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Aug 2017 — Jun 2018 [monthly]
Recruiting PHASE1
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Feb 2017 — Aug 2017 [monthly]
Recruiting PHASE1
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE1
First recorded
Feb 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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 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.
Contact Information
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .