Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma

Not Applicable

• Conditions: Stereotactic Body Radiotherapy; Hepatocellular Carcinoma; Hepatectomy
• Interventions: Radiation: stereotactic body radiotherapy; Procedure: laparoscopic hepatectomy (surgery)

• Registration Number: NCT03609151
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2018-06-30
• Status Verified: 2018-07
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-08-01
• Last Update Posted: 2018-08-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	stereotactic body radiotherapy	stereotactic body radiotherapy (SBRT)
group A	laparoscopic hepatectomy (surgery)	laparoscopic hepatectomy (surgery)

Primary Outcome Measures

Name	Time	Method
Progression free survival	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	The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression

Secondary Outcome Measures

Name	Time	Method
Local recurrence free survival	From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years	The duration (months) between the date of surgery or the first fraction of SBRT until the date of local recurrence
Overall survival	From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years	The duration (months) between the date of surgery or the first fraction of SBRT until the date of death.

Trial Locations

Locations (1)

the second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China