NCT03416803

Brief Summary

Objectives:

  1. 1.To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis.
  2. 2.To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with HCC with lymph node metastasis under the guidance of a microRNA prediction model.

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 8, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

January 8, 2018

Last Update Submit

February 1, 2018

Conditions

Lymph Node MetastasisHepatocellular CarcinomaRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 2-year overall survival

    The therapeutic effects are mainly evaluated by the 2-year overall survival.

    The outcome measures are assessed up to 2 years.

Study Arms (2)

Radiotherapy

EXPERIMENTAL

Patients in the experimental group, who were at high risk for lymph node metastasis, underwent radiotherapy in the lymphatic drainage area. Radiotherapy was started in lymphatic drainage areas about 1 month after HCC surgery. The range of radiotherapy was hepatic portal area, pancreas circumference, celiac trunk and abdomen Around the aortic lymph drainage area, the dose of radiation 45Gy, conventional segmentation.

Radiation: Radiotherapy

Blank control

NO INTERVENTION

Patients in the control group , who were at high risk for lymph node metastasis，were followed up.

Interventions

RadiotherapyRADIATION

Radiotherapy

Radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients underwent liver tumor resection and pathological diagnosis of HCC in our hospital.
  • The tumor samples of these HCC patients were detected by in situ hybridization with miR-145, miR-31 and miR-92a. We used the previously established HCC lymph node metastasis microRNA prediction model to determine the patients with high-risk lymph node metastasis and low-risk patients at high risk Patients were randomly assigned into treatment group and control group with informed consent.
  • HCC patients were not receive other anti-cancer treatment.
  • Blood routine examination was normal.
  • Child-Pugh grade A, normal liver and kidney function in the normal range (including ALT or ASL within 2.5 times the normal), WBC\> 3 × 109 / L, Hb\> 90g / L, PLT\> 50 × 109 /
  • HCC patients were not receive the history of upper abdominal radiotherapy.
  • sign the informed consent.
  • age 18-75 years old.
  • KPS score 80-100 points.

You may not qualify if:

  • accepted other anti-cancer treatment.
  • Patients was determined to be low-risk lymph node metastasis by the pre-established HCC lymph node metastasis microRNA prediction model.
  • blood and liver and kidney dysfunction.
  • can not control the infection.
  • at the same time the merger of other malignant tumors.
  • while using other experimental drugs or to participate in other clinical trials.
  • serious heart, lung, kidney disease.
  • pregnant or lactating women.
  • serious nervous system disease, can not clearly tell the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphatic MetastasisCarcinoma, Hepatocellular

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Zhongshan Hospital, PhD

    Fudan University, Shanghai,China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaochong Zeng, Phd

CONTACT

13817076800zeng.zhaochong@zs-hospital.sh.cn

Zuolin Xiang, Phd

CONTACT

13701816716xiangzuolinmd@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 31, 2018

Study Start

February 1, 2018

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

CN(1)