CClinicalTrials.gg
Status unknownNCT02678806RHCC:BCLC-AUpdated Jul 10, 2018

Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) and / or Microvascular Invasion

An interventional study of Postoperative radiotherapy and Postoperative TACE in HepatoCellular Carcinoma, sponsored by Guangxi Medical University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-07-10.

Sponsored by Guangxi Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
620
Allocation
Randomized
Sex
All
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Study 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.

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Conditions studied

  • HepatoCellular Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 620 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

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Lead sponsor

Guangxi Medical University is the lead sponsor of 68 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
620 participants (estimated)

Study arms

  • 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

  • Active comparator
    Postoperative TACE group

    Drug: Postoperative TACE

Interventions

  • RadiationPostoperative 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

  • DrugPostoperative 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.

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What researchers measure

Primary outcomes

  1. overall survival

    Time frame: 5years

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Study locations

1 of 1 sites recruiting
  • TaoBai
    Nanning, Guangxi 530000, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02678806
Lead sponsor
Guangxi Medical University
Responsible party
TaoBai (Researcher, Guangxi Medical University) — Principal investigator
First posted
Feb 10, 2016
Start date
Nov 1, 2017
Primary completion
Nov 1, 2018 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Jul 10, 2018

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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