Hepatocellular Carcinoma (HCC)
Conditions
Interventions
Group 1: Intervention group: Patients with hepatocellular, non-metastatic carcinoma are treated. Irradiation is hypofractionated with proton therapy. Depending on the distance of the tumor to the gast
Sponsors
Universitätsklinikum Essen, Klinik für Partikeltherapie, Westdeutsches Protonentherapiezentrum Essen (WPE)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. HCC stage BCLC A or B confirmed histologically or by imaging a. For definitive irradiation; or b. As a bridging measure to transplantation. 2. Age = 18 years. 3. Surgery has been ruled out or patient admitted for transplant with expected waiting time for donor organ. 4. Activity status according to ECOG /WHO < 2. 5. Written informed consent to participate in the study. 6. Patients with portal hypertension or previously known esophageal varices: endoscopic examination and adequate therapy 3 months before study entry.
Exclusion criteria
Exclusion criteria: 1. Pre-irradiation in the area of the liver or SIRT. 2. Possibility of curative resection 3. Tumor stage BCLC C and D 4. Medical or psychiatric limitations that prevent the delivery of radiation treatment or affect compliance for treatment and follow-up 5. Pregnancy or unwillingness to use contraception 6. Ability to adequately spare surrounding gastrointestinal organs 7. Patients with Child-Pugh score B8-9 or C 8. Life expectancy 700cc) 10. Inadequate liver function defined as: - Bilirubin > 3 mg/dl - Albumin < 2.5 g/dl 11. Age < 18 years 12. No written consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of acute and late side effects - Occurrence of recurrences/progresses - Survival until transplantation or 12 months after definitive proton therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - Quality of life before, during and after proton therapy - Tumor response under radiation as radiological analysis of CTs/MRIs. - Biochemical control of possible liver toxicity, renal toxicity and systemic inflammation due to irradiation and laboratory evaluation of tumor control - Determination of total tumor cfDNA concentration in plasma and cfDNA fragment length in therapy course and follow-up. | — |
Countries
Germany
Contacts
Public ContactChristine Hansel
Westdeutsches Protonentherapiezentrum Essen (WPE)
Outcome results
None listed