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NCT Number: NCT02571946

Proton Beam Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the agent showed clear survival benefit in two randomized phase III trials, the benefit was modest and response rate was just a few percent. Therefore, other loco-regional modalities, like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including portal vein tumor thrombosis (PVTT).

With the advancement of conformal RT techniques, RT was actively applied in HCC, especially in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose.

Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively.

In those background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients combined with PVTT.

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Key information

Conditions

Liver Neoplasm Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Portal Vein Tumor Thrombosis Proton Therapy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hepatocellular carcinoma (HCC) patients
  • pathologically proven
  • HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline
  • Portal vein tumor thrombosis (main, first branch, segmental)
  • Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
  • 20 or more age
  • Eastern Cooperative Oncology Group performance status 0 to 2 within 1 week before participate
  • Adequate bone marrow function (absolute neutrophil count ≥ 1.0 x 109/l, platelet ≥ 30 x 109/l, hemoglobin ≥ 8 g/dl)
  • Adequate liver/renal function within 1 week before participate
  • Child-Pugh class A, B, or early C (score ≤ 10)
  • Total bilirubin <3.0 mg/dL, Prothrombin time/International normalized ratio <1.7, Albumin≥2.8g/dL, Aspartate aminotransferase/alanine aminotransferase<6 times of upper normal limit
  • Serum creatinine < 1,5 x upper normal limit, glomerular filtration rate > 50 ml/min Informed consent
  • Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of RT and for at least 28 days following the last dose of sorafenib (whichever is later).

Exclusion criteria

  • Uncontrolled hepatic encephalopathy
  • Previous history of upper abdominal radiotherapy
  • Status of pregnancy or breast feeding
  • Less than 12 weeks of expected survival
  • Uncontrolled ascites
  • Combined with disease known as radiosensitive disorder (connective tissue disorder, Ataxia-telangiectasia)
  • Hard to maintain stable respiration less than 5 minutes related with respiratory disease
  • Combined with uncontrolled severe acute disease other than liver

Treatment and study plan

Proton beam therapy

Radiation

Primary outcomes

  1. one-year overall survival

    Time frame: one-year after proton beam therapy

Secondary outcomes

  1. 1 month objective response rate

    Time frame: 1 month after proton beam therapy

  2. 3 month objective response rate

    Time frame: 3 months after proton beam therapy

  3. 1 month portal vein tumor thrombosis response rate

    Time frame: 1 month after proton beam therapy

  4. 3 month portal vein tumor thrombosis response rate

    Time frame: 3 month after proton beam therapy

  5. 1 year progression free survival

    Time frame: one-year after proton beam therapy

  6. 1 year local progression free survival

    Time frame: one-year after proton beam therapy

  7. 1 year portal vein tumor thrombosis progression free survival

    Time frame: one-year after proton beam therapy

  8. Adverse event

    Time frame: one-year after proton beam therapy

  9. 1 month Quality of life assessment compared with baseline

    Time frame: 1 month after proton beam therapy

  10. 3 month Quality of life assessment compared with baseline

    Time frame: 3 month after proton beam therapy

  11. 6 month Quality of life assessment compared with baseline

    Time frame: 6 month after proton beam therapy

  12. Indocyanine green test change compared with baseline

    Time frame: 3 month after proton beam therapy

  13. Hepatobiliary phase signal change after proton beam therapy

    Time frame: 3 month after proton beam therapy

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Feasibility of High Dose Proton Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Prospective Phase II Trial

Acronym: PTHP

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2015
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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