Adjuvant radiotherapy after surgery for liver cancer with narrow margins

Randomized Study of Adjuvant Radiotherapy After Curative Resection of Hepatocellular Carcinoma With Narrow Margin (≤1 cm)

This study is testing if adding radiation therapy after surgery can help prevent liver cancer from coming back in patients who had a narrow margin during their surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03732105 on ClinicalTrials.gov

What this trial studies

The RAISE trial is a multicenter randomized controlled trial designed to evaluate the effectiveness of adjuvant radiotherapy in preventing recurrence of hepatocellular carcinoma (HCC) in patients who have undergone curative resection with narrow margins of ≤ 1 cm. A total of 148 patients will be randomly assigned to either a surgery-only group or a surgery plus radiotherapy group, with the latter receiving Intensity Modulated Radiation Therapy (IMRT) within 1-3 months post-surgery. The primary goal is to determine if the addition of radiotherapy can prolong recurrence-free survival in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have undergone R0 resection for HCC with a narrowest margin of ≤ 1 cm and no residual tumors.

Not a fit: Patients with multiple tumors, preoperative imaging showing tumor thrombus, or those with certain comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in patients with hepatocellular carcinoma after surgery.

How similar studies have performed: Previous studies have shown promising results with adjuvant radiotherapy in similar contexts, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Age 18 - 75 years.
2. HCC who underwent R0 resection with pathological confirmation.
3. The narrowest margin is less than or equal to 1 cm.
4. No residual tumors after surgery based on postoperative CT or MR images in 4-6 weeks.
5. ECOG PS ≤ 1.
6. Child-Pugh score 5-7.
7. Expected life expectancy ≥ 6 months.
8. Blood, liver, and kidney functions meet the following criteria: 1)Neutrophil counts ≥ 1.5×109/L; 2)Platelet counts ≥ 60×109/L; 3)Hemoglobin concentration ≥ 90g/L; 4)Serum albumin concentration ≥ 30g/L; 5)Bilirubin ≤ 1.5 × upper limit of normal; 6)AST and ALT \< 3× ULN; 7)Extended prothrombin time not exceeding 3s of ULN; 8)Creatinine \< 1.5× ULN.

Exclusion Criteria:

1. Preoperative imaging revealed tumor thrombus in the portal vein, hepatic vein, bile duct, or extrahepatic metastasis.
2. The number of tumors ≥4.
3. Pregnant or lactating women or subjects scheduled for contraceptive procedures within 2 years.
4. Patients with concomitant HIV or syphilis infection.
5. Patients with concurrent or other malignancies within 5 years before enrollment.
6. Patients receiving allogeneic organ transplantation.
7. Patients with severe dysfunction of the heart, kidneys or other organs.
8. Participated in clinical trials of other drugs within 12 months before enrollment.

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Ming Kuang, PhD — First Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Ming Kuang, PhD

Conditions Hepatocellular Carcinoma; Radiotherapy; Hepatectomy