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A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma

Primary Purpose

Lymph Node Metastasis, Hepatocellular Carcinoma, Radiotherapy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Radiotherapy

About this trial

This is an interventional prevention trial for Lymph Node Metastasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

180 Fenglin RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Radiotherapy

Blank control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

2-year overall survival

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03416803

First Posted

January 8, 2018

Last Updated

February 1, 2018

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03416803

Brief Title

A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma

Official Title

Prediction of Lymph Node Metastasis in Hepatocellular Carcinoma and the Study of Individualized Radiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2018 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Objectives: To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis. 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.

Detailed Description

First, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as HCC . Then，performing the detection of miR-145, miR-31 and miR-92a by using the HCC lymph node metastasis microRNA correlation prediction model established in our previous study. The patients are judged as high risk of lymph node metastasis and low risk Patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups. Last, Patients enrolled in the treatment group were treated with radiotherapy and followed up.

6. Conditions and Keywords

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

Lymph Node Metastasis, Hepatocellular Carcinoma, Radiotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Blank control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Radiotherapy

Primary Outcome Measure Information:

Title

2-year overall survival

Description

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

Time Frame

The outcome measures are assessed up to 2 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

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

Zhaochong Zeng, Phd

Phone

13817076800

zeng.zhaochong@zs-hospital.sh.cn

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

Zuolin Xiang, Phd

Phone

13701816716

xiangzuolinmd@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhongshan Hospital, PhD

Organizational Affiliation

Fudan University, Shanghai,China

Official's Role

Principal Investigator

Facility Information:

Facility Name

180 Fenglin Road

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhaochong Zeng, Phd

Phone

86-13817076800

zeng.zhaochong@zs-hospital.sh.cn

12. IPD Sharing Statement

Learn more about this trial

A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma

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