RecruitingNot ApplicableNCT03732105
Randomized Study of Adjuvant Radiotherapy After Curative Resection of HCC With Narrow Margin (RAISE)
Randomized Study of Adjuvant Radiotherapy After Curative Resection of Hepatocellular Carcinoma With Narrow Margin (≤1 cm)
Sponsor
Sun Yat-sen University
Enrollment
148 participants
Start Date
Aug 8, 2018
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria8
- 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.
Interventions
RADIATIONSurgery-radiotherapy
Patients in the surgery-radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03732105
Related Trials
Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients
NCT056298451 location
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
NCT059417413 locations
Prospective Clinical Validation of Next Generation Sequencing (NGS) and Patient-Derived Tumor Organoids (PDO) Guided Therapy in Patients With Advanced/ Inoperable Solid Tumors
NCT060775911 location
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
NCT0552895214 locations
Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients
NCT054683592 locations