Clinical trial NCT03609268: Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma
Official title: Effects of Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Hepatocellular Carcinoma
Microwave Ablation
Stereotactic Body Radiotherapy
Keywords: Recurrent Hepatocellular Carcinoma
Microwave ablation
Stereotactic body radiotherapy
Small liver cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.

Detailed description: Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, group B patients receive SBRT. The 3-year progression free survival, 3-year local recurrence free survival, 3-year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to MWA.

Eligibility criteria: Inclusion Criteria:

1. 18 years old and above.
2. Clinical or pathological diagnosis of recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.)
3. Small hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis
4. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency
5. The neutrophil count is at least 1.0\*10\^9/ml, and the platelet count is at least 50\*10\^9/ml. Hemoglobin is at least 80g/L.
6. Men or women with fertility are willing to take contraceptive measures during the trial
7. Eastern Cooperative Oncology Group score 0-1 points
8. Expected survival period \> 3 months
9. Voluntary participation and signing of informed consent

Exclusion Criteria:

1. Patients who have undergone chemoradiation or targeted therapy for liver cancer
2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points
3. Total bilirubin \>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
4. Patients undergoing major surgery within 1 month of study initiation
5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years)
6. Researchers consider it inappropriate to participate in the test

Primary outcomes:
measure: progression free survival
timeFrame: From the date of MWA or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years.
Secondary outcomes:
measure: local recurrence free survival
timeFrame: From the date of MWA or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
measure: overall survival
timeFrame: From the date of MWA or the first fraction of SBRT until the date of death, assessed up to 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References: