liver cancer
Conditions
Interventions
Trial group:patients underwent microwave ablation after enrollment
Control group:patients were treated with SBRT after enrollment
Sponsors
Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. between the ages of 18 and 75 years, and of either sex 2. recurrent small hepatocellular carcinoma based on a history of partial hepatectomy for primary hepatocellular carcinoma and the American Association for the Study of Liver Diseases diagnostic criteria for HCC; and 3. R0 resection of the primary tumor without visible vascular invasion and extrahepatic distant metastases; and 4. no residual disease detected within the first 2 months after initial hepatectomy; and 5. RHCC with a single diameter of =3cm and the number of nodules =3; 6. The RHCC is located at least 1.0 cm from the adjacent gastrointestinal tract, hepatic hilum, vena cava or main hepatic vein, gallbladder, and the base of the diaphragm, and is technically amenable to treatment by SBRT or percutaneous ablation. 7. The physical status score of tumor patients follows the Eastern Cooperative Oncology Group ECOGPS score of 0 to 1 (0 for normal activity; 1 for mild symptoms, comfortable with life, and able to engage in light physical activity); 8. liver function grade Child-Pugh grade A or B; and 9. prothrombin time (PT) less than 4 seconds from normal control; 10. absence of hepatic encephalopathy or/and ascites of more than moderate volume. 11. Renal function and cardiopulmonary function are essentially normal. 12. Gastroscopy of esophageal veins without severe varices, no active peptic ulcers 13. Hemoglobin =90g/L, white blood cell count =3.0×109/L, neutrophil count =1.5×109/L, platelet count =40×109/L. 14. No clear manifestation of malignant disease; 15. expected life expectancy greater than three months, no pregnancy, and no HIV or syphilis infection; 16. those who can understand the circumstances of this study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) History of other malignant tumors within 5 years prior to enrollment; (2) Portal hypertension diagnosed by preoperative enhanced abdominal CT and endoscopy, history of esophageal variceal bleeding, severe hypersplenism syndrome, or refractory ascites; (3) History of any anti-RHCC therapy prior to enrollment, including transcatheter arterial chemoembolization, radiofrequency ablation, radiotherapy, and chemotherapy; (4) History of spontaneous tumor rupture; (5) Postoperative pathology suggestive of metastatic cancer or primary cancer in other tissue types; (6) History of cerebrovascular accident within 6 months prior to enrollment; (7) History of unstable angina, myocardial infarction, or heart failure within the past 6 years months prior to inclusion; (8) History of surgical treatment for other diseases within 4 weeks prior to enrollment; (9) Severe lung disease (e.g., pulmonary fibrosis, severe emphysema, pulmonary heart disease); or a forced expiratory volume in 1 second (FEV1) 50 mmHg; (10) Serum creatinine > 1.25 times the upper limit of normal; (11) Poorly controlled acute or active infection (infection-induced fever >38°C); (12) Poorly controlled hypertension or diabetes mellitus; (13) Severe mental illness or disorder; (14) Suspected systemic or localized lymphadenopathy on imaging studies; (15) Receipt of systemic administration of corticosteroids; (16) Requirement for concomitant surgical treatment of other diseases; (17) Pregnant or lactating women; (18) Other serious underlying medical conditions; (19) Inability or refusal to comply with the rules (20) Participation in other clinical trials (21) Refusal to provide informed consent Key exclusion criteria were history of other malignancies within the past 5 years, history of spontaneous tumor rupture, history of prior anti-RHCC therapy, serious concomitant disease, acute or active infectious disease, pregnancy, or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival ; | — |
Countries
China
Contacts
Public ContactWeixing Guo
Third Affiliated Hospital of Naval Medical University
Outcome results
None listed