Tests proton therapy for liver cancer in adults with hepatocellular carcinoma

Trial details

Who runs it

University of Aarhus

Trial code

NCT05203120

Record updated

11 May 2023

Original description

350 new cases of hepatocellular carcinoma (HCC) are diagnosed in Denmark each year, but the overall prognosis is poor with a 1-year survival rate of less than 40% and a 5-year survival rate of 10% for the entire patient group.Read full original descriptionShow less

A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma

350 new cases of hepatocellular carcinoma (HCC) are diagnosed in Denmark each year, but the overall prognosis is poor with a 1-year survival rate of less than 40% and a 5-year survival rate of 10% for the entire patient group.

This national phase II non-randomized single-arm study of proton therapy in HCC is conducted with the aim to offer a safe and efficient radiation treatment to fragile patients with reduced dose to the normal liver compared to conventional photon-based radiotherapy.

Inclusion: Patients with HCC based on classical radiologic findings as defined by the American Association for the Study of Liver Diseases (AASLD) criteria or verified by biopsy; No extra-hepatic disease; Deemed ineligible for resection or Radiofrequency Ablation (RFA), or the patients should refuse RFA or surgery; Age ≥ 18 years; Performance status ≤ 2; Total diameter of tumor(s) ≤ 12 cm and a maximum of 3 tumors; Adequate liver function as measured by Child-Pugh score (Child-Pugh score ≤ 8), or absence of cirrhosis; Has recovered adequately from toxicity and/or complications from any previous local interventions; Patients with past or ongoing hepatitis C infection are allowed, but treatment for hepatitis C must have been completed one month before study entry; Patients with hepatitis B infection is allowed if antiviral therapy have been given for at least 4 weeks and Hepatitis B Virus (HBV) viral load is less than 100 IU/ml. The active therapy must continue throughout the radiation therapy. Patients who are Total hepatitis B core antibody (anti-HBc)(+), negative for Hepatitis B surface antigen (HbsAg) and negative or positive for Hepatitis B surface antibody (anti-HBs) with a HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis; Adequate organ function; hematological: hemoglobin ≥ 6 mmol/l, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 50 x 109/L; hepatic: bilirubin ≤ 1.5 x ULN, alanin-aminotransferase (ALAT) ≤ 1.5 x ULN; renal: creatinine ≤ 1.5 x ULN; Ability to adhere to procedures for study and follow-up; Signed informed consent to participate; Final decisions on inclusion and treatment with proton therapy are at the discretion of the investigator.

Exclusion: Previous x-ray-based radiotherapy in the liver; Previous Selective internal radiation therapy (SIRT); Patients with metal implants where beam entrance through the metal implants cannot be avoided (not applicable for fiducial markers implanted for radiotherapy use); Patients for whom it is not possible to implant fiducial markers e.g. due to insufficient coagulation of the blood; Episode of bleeding esophageal varices within the past month. If active bleeding from esophageal varices has occurred, a gastroscopy should be performed 4 weeks after the bleeding episode to ensure maximum grade 1 varices; Child Pugh score >8; Tumor less than 1 cm from any critical organs at risk (OAR) (duodenum, kidney, stomach, intestines); Episode of hepatic encephalopathy within the last 6 months; Uncontrolled ascites with need for drainage > 1 per month; Patients for whom it is not possible to produce a robust treatment plan following the technical guidelines (Appendix A).

ClinicalTrials.gov NCT05203120