NCT05203120 A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma
| NCT ID | NCT05203120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-04-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Britta Weber, MD PhD
PRINCIPAL INVESTIGATOR
Danish Center of Particle Therapy
Frequently Asked Questions
Who can join the NCT05203120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05203120 currently recruiting?
Yes, NCT05203120 is actively recruiting participants. Contact the research team at britta.weber@auh.rm.dk for enrollment information.
Where is the NCT05203120 trial being conducted?
This trial is being conducted at Herlev, Denmark, Aarhus, Denmark, Odense, Denmark.
Who is sponsoring the NCT05203120 clinical trial?
NCT05203120 is sponsored by University of Aarhus. The principal investigator is Britta Weber, MD PhD at Danish Center of Particle Therapy. The trial plans to enroll 50 participants.
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