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

Launched by SUN YAT-SEN UNIVERSITY · Nov 4, 2018

Keywords

ClinConnect Summary

The RAISE trial is a study that is looking at whether adding radiation therapy after surgery can help prevent the return of liver cancer (specifically, hepatocellular carcinoma or HCC) in patients who have had their tumors removed but have a very small amount of healthy tissue left around the tumor (less than or equal to 1 cm). The goal is to see if this additional treatment can improve outcomes for patients who are at risk of their cancer coming back.

To participate in this trial, patients need to be between 18 and 75 years old and have recently undergone surgery to remove their liver cancer, with no remaining cancer visible on follow-up scans. They should also be in relatively good health, with specific blood and liver function levels. If eligible, participants will join a randomized group where some will receive the radiation therapy while others will not, allowing researchers to compare the results. This study is currently recruiting participants from various centers, and it aims to provide important information that could help improve treatment options for patients with this type of cancer.

Gender

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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.