218 Participants NeededMy employer runs this trial

Radiotherapy for Early Stage Liver Cancer

(SOCRATES HCC Trial)

Recruiting at 1 trial location
MY
Overseen ByMichael Yan, MD MPH FRCPC DABR
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating early-stage liver cancer using focused radiation known as Stereotactic Ablative Body Radiotherapy (SABR). Researchers aim to determine if SABR is more effective than current treatments such as heat probes, chemotherapy, or injecting radioactive particles. They will assess cancer control and the treatment's impact on quality of life. Individuals with a single liver tumor who are not eligible for surgery or have declined it might be suitable candidates for this study. As an unphased trial, this study provides patients with the opportunity to explore innovative treatment options that could enhance their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this radiotherapy technique is safe for treating early stage liver cancer?

Research has shown that Stereotactic Ablative Body Radiotherapy (SABR) offers a promising treatment for early-stage liver cancer. Studies indicate that SABR effectively controls tumors in about 90-95% of cases, meaning the tumor stops growing or shrinks in most patients treated with SABR.

Additionally, SABR is considered safe. Many studies report an acceptable level of side effects, with most patients not experiencing severe issues. Specifically, one study found that SABR caused few serious health problems when used for liver tumors, suggesting it is generally well-tolerated.

In summary, SABR is both effective and safe for many patients with liver cancer. It controls tumors well and has a low risk of causing serious side effects, making it a strong option for treating early-stage liver cancer.12345

Why are researchers excited about this trial?

Stereotactic Ablative Body Radiotherapy (SABR) is unique because it offers a highly precise form of radiation therapy for early-stage liver cancer. Unlike traditional treatments like surgical resection or transarterial chemoembolization, SABR delivers concentrated doses of radiation directly to the tumor while sparing surrounding healthy tissue. This precision reduces side effects and potentially improves recovery time. Researchers are excited about SABR because it could provide a non-invasive yet highly effective treatment option for patients who might not be suitable candidates for surgery.

What evidence suggests that SABR is effective for early stage liver cancer?

Research has shown that Stereotactic Ablative Body Radiotherapy (SABR), which participants in this trial may receive, effectively treats early-stage liver cancer. Studies indicate that about 90% of patients survive one year after treatment, and 75% survive after two years. SABR also provides excellent local control, keeping the cancer contained with success rates as high as 95% after three years. Additionally, SABR has a manageable side effect profile, causing few unwanted effects. Overall, evidence suggests SABR is a strong option for managing early-stage liver cancer.13467

Are You a Good Fit for This Trial?

This trial is for people with early stage liver cancer (HCC) who are eligible for local treatments. Participants should not have advanced disease or other serious health issues that would prevent them from receiving the study treatments.

Inclusion Criteria

I am at least 18 years old and can give written consent.
Child-Pugh score ≤B7 with no or diuretic-controlled ascites
Platelets ≥50x10^9/L, Haemoglobin ≥80 g/L, Neutrophils ≥1.0x10^9/L, INR <1.8 (except if on therapeutic anticoagulation)
See 4 more

Exclusion Criteria

Pregnancy
I have liver cancer that has spread or invaded blood vessels or other organs.
I have been treated for liver cancer in the past 2 years.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either SABR or the current standard of care, which may include thermal ablation, TACE, or TARE

8-12 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes, including progression-free survival and overall survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Stereotactic Ablative Body Radiotherapy (SABR)

Trial Overview

The study compares a precise form of radiation therapy called SABR to standard treatments like heating probes, chemotherapy, or radioactive particles delivered directly to the tumor. Patients are randomly assigned to one group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Standard Of Care TreatmentExperimental Treatment1 Intervention
Group II: Radiation TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Trans Tasman Radiation Oncology Group

Collaborator

Trials
50
Recruited
16,600+

Australasian Gastro-Intestinal Trials Group

Collaborator

Trials
26
Recruited
8,000+

Citations

Review Stereotactic body radiotherapy in early-stage ...

The pooled results of the 1-, 2-, and 3-year overall survival rate were 90% (95% CI 85%-94%), 75% (95% CI 63%-87%), and 59% (95% CI 45%-73%), respectively.

Stereotactic Body Radiation Therapy for Hepatocellular ...

The 3- and 5-year OS rates after SBRT were 57% 47%-66%) and % favorable pooled 5-year LC and OS rates of 82% (95% CI, 74%-88%) and 40%

The use of artificial intelligence in stereotactic ablative body ...

SABR-IO yielded superior survival outcomes (3-year OS: 63.9% vs. 43.3%, P = 0.034), an improved time to progression, and a higher overall ...

Stereotactic Ablative Radiotherapy (SABR/SBRT) for ...

The results from these series show SABR to be an effective treatment for HCC, with reasonable toxicity profiles.

Stereotactic ablative radiotherapy for hepatocellular ...

Multiple centers around the world have reported long-term outcomes with excellent local control, survival and acceptable toxicity profiles.

Stereotactic Body Radiotherapy for Hepatocellular Carcinoma

Most studies reported an attainment of local control in 90–95% of cases (Table 2). The overall survival varied among the studies, which seemed ...

The use of artificial intelligence in stereotactic ablative ...

SABR has emerged as a promising treatment option for patients with localized HCC, offering high local control rates and favorable toxicity profiles.