Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416803
Recruitment Status : Unknown
Verified January 2018 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : January 31, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:

Objectives:

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

Condition or disease Intervention/treatment Phase
Lymph Node Metastasis Hepatocellular Carcinoma Radiotherapy Radiation: Radiotherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prediction of Lymph Node Metastasis in Hepatocellular Carcinoma and the Study of Individualized Radiotherapy
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Radiotherapy
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
Radiotherapy

No Intervention: Blank control
Patients in the control group , who were at high risk for lymph node metastasis,were followed up.



Primary Outcome Measures :
  1. 2-year overall survival [ Time Frame: The outcome measures are assessed up to 2 years. ]
    The therapeutic effects are mainly evaluated by the 2-year overall survival.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients underwent liver tumor resection and pathological diagnosis of HCC in our hospital.
  2. 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.
  3. HCC patients were not receive other anti-cancer treatment.
  4. Blood routine examination was normal.
  5. 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 /
  6. HCC patients were not receive the history of upper abdominal radiotherapy.
  7. sign the informed consent.
  8. age 18-75 years old.
  9. KPS score 80-100 points.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416803


Contacts
Layout table for location contacts
Contact: Zhaochong Zeng, Phd 13817076800 zeng.zhaochong@zs-hospital.sh.cn
Contact: Zuolin Xiang, Phd 13701816716 xiangzuolinmd@hotmail.com

Locations
Layout table for location information
China
180 Fenglin Road Recruiting
Shanghai, China, 200032
Contact: Zhaochong Zeng, Phd    86-13817076800    zeng.zhaochong@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhongshan Hospital, PhD Fudan University, Shanghai,China
Layout table for additonal information
Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03416803    
Other Study ID Numbers: ZS-LNM-2017
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasm Metastasis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases