Overview
RAISE is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in HCC patients with narrow margin (≤ 1 cm) after curative resection.
Description
RAISE trial will recruit 148 patients, and they will be randomized (1:1) to two groups (the surgery group and the surgery-radiotherapy group). Random assignment was stratified by the condition of MVI and tumor size. All patients in the surgery-radiotherapy group received Intensity Modulated Radiation Therapy (IMRT) within 1-3 months after surgical resection. The prescription dose was planned at 50 gray in 25 fractions over 5-6 weeks. The trial is to verify whether adjuvant radiotherapy prolongs recurrence-free survival in patients with a narrow resection margin.
Eligibility
Inclusion Criteria:
- Age 18 - 75 years.
- HCC who underwent R0 resection with pathological confirmation.
- The narrowest margin is less than or equal to 1 cm.
- No residual tumors after surgery based on postoperative CT or MR images in 4-6 weeks.
- ECOG PS ≤ 1.
- Child-Pugh score 5-7.
- Expected life expectancy ≥ 6 months.
- 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:
- Preoperative imaging revealed tumor thrombus in the portal vein, hepatic vein, bile duct, or extrahepatic metastasis.
- The number of tumors ≥4.
- Pregnant or lactating women or subjects scheduled for contraceptive procedures within 2 years.
- Patients with concomitant HIV or syphilis infection.
- Patients with concurrent or other malignancies within 5 years before enrollment.
- Patients receiving allogeneic organ transplantation.
- Patients with severe dysfunction of the heart, kidneys or other organs.
- Participated in clinical trials of other drugs within 12 months before enrollment.