- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03416803
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:
- 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Shanghai, Kina, 200032
- Rekrytering
- 180 Fenglin Road
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Kontakt:
- Zhaochong Zeng, Phd
- Telefonnummer: 86-13817076800
- E-post: zeng.zhaochong@zs-hospital.sh.cn
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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Strålbehandling
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Inget ingripande: Blank control
Patients in the control group , who were at high risk for lymph node metastasis,were followed up.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
2-year overall survival
Tidsram: The outcome measures are assessed up to 2 years.
|
The therapeutic effects are mainly evaluated by the 2-year overall survival.
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The outcome measures are assessed up to 2 years.
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Zhongshan Hospital, PhD, Fudan University, Shanghai,China
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Neoplastiska processer
- Carcinom
- Karcinom, hepatocellulärt
- Neoplasma Metastas
- Lymfatisk metastasering
Andra studie-ID-nummer
- ZS-LNM-2017
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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