Proton therapy for patients with liver cancer

A National Phase II Study of Proton Therapy in Hepatocellular Carcinoma

This study is testing if proton therapy can be a safer and more effective treatment for liver cancer in patients who can't have surgery or other local treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Aarhus (other)
• Drugs / interventions: radiation
• Locations: 3 sites (Herlev, Capital Region and 2 other locations)
• Trial ID: NCT05203120 on ClinicalTrials.gov

What this trial studies

This national phase II study investigates the use of proton therapy as a treatment for hepatocellular carcinoma (HCC) in Denmark. The study aims to provide a safer and more effective radiation option for patients who are not candidates for surgery or other local treatments. A total of 50 patients will be enrolled over three years, receiving proton therapy while undergoing regular monitoring through CT scans and blood tests for circulating tumor DNA. The goal is to improve treatment outcomes and prognosis for patients with HCC.

Who should consider this trial

Good fit: Ideal candidates include adults with hepatocellular carcinoma who are not eligible for surgery or radiofrequency ablation and have adequate liver function.

Not a fit: Patients with extra-hepatic disease or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with hepatocellular carcinoma.

How similar studies have performed: While proton therapy is a novel approach for treating hepatocellular carcinoma, similar studies in other cancers have shown promising results.

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.

Where this trial is running

Herlev, Capital Region and 2 other locations

• Herlev Hospital — Herlev, Capital Region, Denmark (RECRUITING)
• Aarhus University Hospital — Aarhus, Central Jutland, Denmark (RECRUITING)
• Odense University Hospital — Odense, Syd, Denmark (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Britta Weber, MD PhD — Danish Center of Particle Therapy
• Study coordinator: Britta Weber, MD PhD

Conditions: Hepatocellular Carcinoma