Randomized Study of Adjuvant Radiotherapy After Curative Resection of HCC With Narrow Margin (RAISE)

Summary

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.

Eligibility

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.

Conditions6

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