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Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma, Hepatectomy, Stereotactic Body Radiotherapy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

laparoscopic hepatectomy (surgery)

stereotactic body radiotherapy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Early-stage liver cancer, Hepatectomy, Stereotactic body radiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years old and above.
Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy).
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.
No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency.
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.
Men or women with fertility are willing to take contraceptive measures during the trial.
Eastern Cooperative Oncology Group score 0-1 points.
Expected survival period > 3 months.
Voluntary participation and signing of informed consent.

Exclusion Criteria:

Patients who have undergone chemoradiation or targeted therapy for liver cancer.
Recent hematemesis due to portal hypertension.
Child-Pugh score ≥10 points.
Total bilirubin>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting.
Patients undergoing major surgery within 1 month of study initiation
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)
Researchers consider it inappropriate to participate in the test

Sites / Locations

the second affiliated hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

group A

group B

Arm Description

laparoscopic hepatectomy (surgery)

stereotactic body radiotherapy (SBRT)

Outcomes

Primary Outcome Measures

Progression free survival

The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression

Secondary Outcome Measures

Local recurrence free survival

The duration (months) between the date of surgery or the first fraction of SBRT until the date of local recurrence

Overall survival

The duration (months) between the date of surgery or the first fraction of SBRT until the date of death.

Full Information

NCT ID

NCT03609151

First Posted

July 2, 2018

Last Updated

July 24, 2018

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT03609151

Brief Title

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

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 30, 2018 (Actual)

Primary Completion Date

May 31, 2021 (Anticipated)

Study Completion Date

May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Hepatectomy, Stereotactic Body Radiotherapy

Keywords

Hepatocellular carcinoma, Early-stage liver cancer, Hepatectomy, Stereotactic body radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Active Comparator

Arm Description

laparoscopic hepatectomy (surgery)

Arm Title

group B

Arm Type

Experimental

Arm Description

stereotactic body radiotherapy (SBRT)

Intervention Type

Procedure

Intervention Name(s)

laparoscopic hepatectomy (surgery)

Intervention Description

Patients receive laparoscopic hepatectomy.

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiotherapy

Intervention Description

Patients receive stereotactic body radiotherapy(SBRT)

Primary Outcome Measure Information:

Title

Progression free survival

Description

The duration (months) between the date of surgery or the first fraction of SBRT until the date of first progression

Time Frame

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 Outcome Measure Information:

Title

Local recurrence free survival

Description

The duration (months) between the date of surgery or the first fraction of SBRT until the date of local recurrence

Time Frame

From the date of surgery or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years

Title

Overall survival

Description

The duration (months) between the date of surgery or the first fraction of SBRT until the date of death.

Time Frame

From the date of surgery or the first fraction of SBRT until the date of death, assessed up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old and above. Clinical or pathological diagnosis of hepatocellular carcinoma, initial treatment (without surgery, radiotherapy, chemotherapy or targeted therapy). 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. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency. 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. Men or women with fertility are willing to take contraceptive measures during the trial. Eastern Cooperative Oncology Group score 0-1 points. Expected survival period > 3 months. Voluntary participation and signing of informed consent. Exclusion Criteria: Patients who have undergone chemoradiation or targeted therapy for liver cancer. Recent hematemesis due to portal hypertension. Child-Pugh score ≥10 points. Total bilirubin>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times. who was considered unsuitable for surgery after hepatobiliary and pancreas multidisciplinary treatment（MDT） meeting. Patients undergoing major surgery within 1 month of study initiation 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) Researchers consider it inappropriate to participate in the test

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qichun Wei, MD,PhD

Phone

+86 571 87783521

qichun_wei@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yongjie Shui, MM

Phone

+86 571 87783521

shui-yongjie@zju.edu.cn

Facility Information:

Facility Name

the second affiliated hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qichun Wei, MD,PhD

Phone

+86 571 87783521

qichun_wei@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Yongjie Shui, MM

Phone

+86 571 87783521

shui-yongjie@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiotherapy and Surgery for Early-stage Hepatocellular Carcinoma

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