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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Radiotherapy; Lymph Node Metastasis
• Intervention / Treatment: Radiation: Radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • 180 Fenglin Road
    • Contact: Zhaochong Zeng, Phd; Phone Number: 86-13817076800; Email: zeng.zhaochong@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Zhongshan Hospital, PhD, Fudan University, Shanghai,China

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Neoplastic Processes; Carcinoma; Carcinoma, Hepatocellular; Neoplasm Metastasis; Lymphatic Metastasis
• Other Study ID Numbers: ZS-LNM-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No