Status:
COMPLETED
RFA Versus SBRT for Recurrent Small HCC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Recurrence rate of hepatocellular carcinoma (HCC)after resection is as high as 65.0%-83.7%.The recurrence of HCC is the most important factor affecting prognosis. Reasonable and effective treatment of...
Detailed Description
Recurrence rate of hepatocellular carcinoma (HCC)after resection is as high as 65.0%-83.7%.The recurrence of HCC is the most important factor affecting prognosis. Reasonable and effective treatment of...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Aged 18-75 years;
- Diagnosed with HCC: The diagnosis of HCC will be confirmed according to the " Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition) " formulated by the National Health Commission of China and the Barcelona Clinic Liver Cancer (BCLC) strategy for prognosis prediction and treatment recommendation of the European Association for the Study of the Liver (EASL);
- Recurrent small HCC: Single hepatocellular carcinoma ≤ 5 cm that recurs after previous curative resection or thermal ablation, with the recurrence time ≥ 3 months from resection/ablation, and without extrahepatic metastasis or vascular invasion at recurrence;
- No contraindications for RFA and SBRT treatment;
- Karnofsky performance score (KPS) ≥ 90;
- Liver function Child-Pugh class A;
- Normal liver volume greater than 800 cm3;
- Expected survival time longer than 6 months;
- The function of important organs meets the following requirements: a. white blood cell ≥ 3×109/L; b. hemoglobin ≥ 80 g/L; c. platelets ≥ 50×109/L; d. blood creatinine ≤ 1.5 times the upper limit; e. prothrombin time (PT) ≤ 3 seconds above control;
- Subject has signed the informed consent form and agreed to the treatment and follow-up schedules according to this protocol;
- Subject must have the ability to understand and voluntarily sign the written informed consent form prior to starting any specific procedure in the study.
- Exclusion criteria
- Presence of extrahepatic metastasis or intrahepatic vascular invasion;
- More than one recurrent lesion, or maximum diameter \> 5 cm;
- Concomitant severe cardiac, pulmonary, renal, or other major organ dysfunction, severe infection or other comorbidities, unable to tolerate treatment;
- History of other malignancies;
- History of allergic reactions to relevant drugs;
- History of organ transplantation;
- During pregnancy or lactation;
- Unable to undergo one of the treatments (RFA or SBRT);
- Concomitantly receiving other anti-tumor therapy (including immunotherapy and targeted therapy);
- Other factors that may affect patient enrollment and evaluation results;
- Refusal to comply with the study protocol requirements for follow-up and refusal to sign the informed consent form.
Exclusion
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04047173
Start Date
August 12 2019
End Date
April 1 2024
Last Update
June 17 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060