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Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) and / or Microvascular Invasion (RHCC:BCLC-A)

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ClinicalTrials.gov Identifier: NCT02678806
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
TaoBai, Guangxi Medical University

Brief Summary:
Hepatocellular carcinoma is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. For hepatocellular carcinoma treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy, etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm and microvascular invasion is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin. To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant Radiotherapy for centrally located hepatocellular carcinoma after narrow margin (<1 cm) hepatectomy on tumor recurrence.

Condition or disease Intervention/treatment Phase
HepatoCellular Carcinoma Radiation: Postoperative radiotherapy Drug: Postoperative TACE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) and / or Microvascular Invasion
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2022

Arm Intervention/treatment
Experimental: Postoperative radiotherapy group
Patients hospitalized in Affiliated Tumor Hospital of Guangxi Medical University from 1st November 2017, who were diagnosed as BCLC-A stage hepatocellular carcinoma, accepted hepatocellular carcinoma resection, pathologically confirmed as narrow margin (the closest distance from margin to tumor capsule < 1cm) and microvascular invasion was found in tumor capsule and adjacent tissues junction were selected and received margin postoperative radiotherapy.
Radiation: Postoperative radiotherapy
The radiotherapy group received prophylactic radiotherapy 1 month after operation. All the patients in the experimental group were treated with 6 to 8 MV X-ray, intensity-modulated irradiation (IMRT) technique, which was divided into 4-5 fields, 2Gy/25 times. 5f/W, total dose 50Gy

Active Comparator: Postoperative TACE group Drug: Postoperative TACE
In the intervention group, TACE was performed in January and March after operation. The femoral artery puncture was performed by Seldinger method, and the cannula was intubated to the hepatic artery by DSA. Then, 50 mg of lobaplatin plus 4 mg of raltitrexed was injected into the vascular artery. The embolic agent was selected as 38.0. % super liquefied iodine solution and / or gelatin sponge particles, the dose is maintained at 5 ~ 20ml. At the end of treatment, a DSA examination again confirmed that the tumor was completely occluded.




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients were pathologically diagnosed as BCLC-A stage hepatocellular carcinomas, liver function were Child-Pugh class A or liver function changed from class B to class A after short-term liver treatment, PS scored 0-1, and accepted hepatocellular carcinomas resection (R0 resection).
  2. No recurrence was found within 3-4 weeks after surgery.
  3. pathologically confirmed as narrow margin (the closest distance from margin to tumor capsule (<1 cm) and microvascular invasion was found in tumor capsule and adjacent tissues junction (material selection and pathological diagnosis were based on "Standardization pathology Guide of primary liver cancer 2015 edition" ).
  4. Postoperative radiotherapy was the only combination therapy within one month after surgery.
  5. Radiation range was margin radiation along and/or joint portal vessels radiotherapy.
  6. No lymph node and distant metastasis before surgery.

Exclusion Criteria:

  1. Patients were pathologically diagnosed as BCLC-B, C, D stage hepatocellular carcinomas, liver function were Child-Pugh class C, PS scored ≥2. Or primary liver cancer patients were pathologically diagnosed as cholangiocarcinoma or mixed type liver cancer. Or patients did not accept hepatectomy.
  2. Patients received transcatheter arterial chemoembolization, chemotherapy, targeted medicine or other anti-cancer therapy before surgery.
  3. Recurrence was found within 3-4 weeks after surgery.
  4. Postoperative adjuvant therapy included treatment other than radiotherapy within one month after surgery.
  5. Radiation range involved lymph node other than portal vein area.
  6. Lymph node and distant metastasis were diagnosed before surgery.

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): NCT02678806


Contacts
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Contact: Tao Bai, MD +86 13878862632 25859373@qq.com

Locations
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China, Guangxi
TaoBai Recruiting
Nanning, Guangxi, China, 530000
Contact: Bai Tao, MD    +86 13878862632    25859373@qq.com   
Sponsors and Collaborators
Guangxi Medical University
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Responsible Party: TaoBai, Researcher, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02678806    
Other Study ID Numbers: GDWTaoBai
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases