Clinical trial NCT03609151: Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma
Official title: Effects of Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma: a Prospective,Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Hepatectomy
Stereotactic Body Radiotherapy
Keywords: Hepatocellular carcinoma
Early-stage liver cancer
Hepatectomy
Stereotactic body radiotherapy
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
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The prognosis of small liver cancer (≤5 cm) with stereotactic body radiotherapy (SBRT) is encouraging, the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, and 3-year overall survival rate around 70%. So far, there is no randomized controlled study comparing SBRT and surgical treatment for early-stage liver cancer. It is hoped that this study will further compare the efficacy of SBRT and surgery for early stage liver cancer.

Detailed description: Early stage liver cancer, according to Milan criteria, are chose for this study. The patients are divided into two groups randomly. Patients in group A receive laparoscopic hepatectomy, 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 surgery.

Eligibility criteria: Inclusion Criteria:

1. 18 years old and above.
2. Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy).
3. Early-stage 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. Recent hematemesis due to portal hypertension.
3. Child-Pugh score ≥10 points.
4. Total bilirubin\>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
5. who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting.
6. Patients undergoing major surgery within 1 month of study initiation
7. 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)
8. Researchers consider it inappropriate to participate in the test

Primary outcomes:
measure: Progression free survival
timeFrame: From the date of surgery 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 surgery 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 surgery 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: