Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05203120
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* Previous x-ray-based radiotherapy in the liver
* Child Pugh score \>8
* Tumor less than 1 cm from any critical organs at risk (OAR) (duodenum, kidney, stomach, intestines).
* Previous Selective internal radiation therapy (SIRT)
* Episode of hepatic encephalopathy within the last 6 months
* Uncontrolled ascites with need for drainage \> 1 per month
* 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.
* 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 produce a robust treatment plan following the technical guidelines (Appendix A)
* Patients for whom it is not possible to implant fiducial markers e.g. due to insufficient coagulation of the blood.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05203120
Study Brief:
Protocol Section:
NCT05203120