NCT03609151

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

July 2, 2018

Last Update Submit

July 24, 2018

Conditions

Hepatocellular CarcinomaHepatectomyStereotactic Body Radiotherapy

Keywords

Hepatocellular carcinomaEarly-stage liver cancerHepatectomyStereotactic body radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

  • Overall survival

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

Study Arms (2)

group A

ACTIVE COMPARATOR

laparoscopic hepatectomy (surgery)

Procedure: laparoscopic hepatectomy (surgery)

group B

EXPERIMENTAL

stereotactic body radiotherapy (SBRT)

Radiation: stereotactic body radiotherapy

Interventions

laparoscopic hepatectomy (surgery)PROCEDURE

Patients receive laparoscopic hepatectomy.

group A
stereotactic body radiotherapyRADIATION

Patients receive stereotactic body radiotherapy(SBRT)

group B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Surgical Procedures, OperativeRadiosurgery

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresInvestigative Techniques

Central Study Contacts

Qichun Wei, MD,PhD

CONTACT

+86 571 87783521qichun_wei@zju.edu.cn

Yongjie Shui, MM

CONTACT

+86 571 87783521shui-yongjie@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

August 1, 2018

Study Start

June 30, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

CN(1)