Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Effects of Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma: a Prospective,Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03609151
• Other study ID #: IR2018001024
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2018
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qichun Wei, MD,PhD
• Phone: +86 571 87783521
• Email: qichun_wei[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatectomy
• Hepatocellular Carcinoma
• Stereotactic Body Radiotherapy

Intervention

Procedure:
• laparoscopic hepatectomy (surgery)
Patients receive laparoscopic hepatectomy.

Radiation:
• stereotactic body radiotherapy
Patients receive stereotactic body radiotherapy(SBRT)

Locations

Country	Name	City	State
China	the second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression	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	Local recurrence free survival	The duration (months) between the date of surgery or the first fraction of SBRT until the date of local recurrence	From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
Secondary	Overall survival	The duration (months) between the date of surgery or the first fraction of SBRT until the date of death.	From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years