Radiotherapy/Apatinib for Adjuvant Treatment of HCC Patients receIved Curative reSEction With Microvascular Invasion

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RAISE is a multicenter phase II randomized 2x2 factorial trial. The purpose is to further investigate both the efficacy and safety of the radiotherapy/apatinib for adjuvant treatment of HCC patients accepted radical resection with microvascular invasion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Angiogenesis Inhibitors; Apatinib

Criteria

Inclusion Criteria:

1. Aged 18--75；

2. Primary treatment of HCC patients was treated with curative surgery. Postoperative pathology was diagnosed as hepatocellular carcinoma with microvascular invasion；

3. No residual and new lesions, no lymph node ,local and distant metastasis were detected after 4 weeks of postoperative ultrasound and enhanced CT/MRI.

4. ECOG 0/1 ;

5. Child-Pugh score 5-6;

6. A life expectancy of 6 months or more；

7. Adequate haematological, liver and renal function Neutrophil count ≥1.5 x 109/L; platelet count> 60 x 109/L; Haemoglobin concentration≥9.0 g/dL; Serum albumin≥ 3.0 g/dL; A total bilirubin of less than 1.5 times upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times upper limit of normal; Prothrombin time ≤3s above the control Serum creatinine concentration of 1.5 times the upper limit of the normal range or less; CCR ≥60ml/min

8. Written informed consent

Exclusion Criteria:

1. with tumor thrombus in the portal veins, hepatic veins, or bile ducts on preoperative radiological imaging

2. >3 tumor nodules in patients with multi-nodular HCC

3. have been treated with radiotherapy, TACE and ablation

4. subjects for pregnant or lactating women or family planning for two years

5. with HIV, HCV, syphilis infection;

6. with other malignant tumors or other malignant tumors within 5 years of entry;

7. organ transplant within 5 years of entry;

8. serious heart, kidney function and other serious organ dysfunction;

9. participated in clinical trials of other drugs within 12 months of entry