Clinical trial NCT03416803: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lymph Node Metastasis
Hepatocellular Carcinoma
Radiotherapy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: 2-year overall survival
timeFrame: The outcome measures are assessed up to 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Fudan University, Shanghai,China
name: Zhongshan Hospital, PhD
role: PRINCIPAL_INVESTIGATOR
References: