CClinicalTrials.gg
Status unknownNCT04202523Updated Dec 17, 2019

Combined Radiotherapy and Radiofrequency Ablation for Hepatocellular Carcinoma

A Phase 3 interventional study of Radiofrequency ablation and IMRT & SBRT in Hepatocellular Carcinoma, sponsored by Guangxi Medical University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by Guangxi Medical University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study summary

Liver cancer is a clinically high-grade malignant tumor, and the current incidence rate is increasing year by year. It has become the third most malignant tumor after gastric cancer and lung cancer, and has a high mortality rate. The patient's five-year survival rate is less than 8.5%, which the second leading cause of cancer death is a serious threat to the health of patients. Surgical resection is the preferred treatment plan for liver cancer. With the development of medical technology, the clinical efficacy of liver cancer has been significantly improved, but postoperative recurrence has not been effectively controlled. According to statistics, the recurrence rate of liver cancer after 5 years is as high as 77.0%. Even for small liver cancer resection, the recurrence rate is 40.0%\~50.0% within 5 years after operation. At the same time, for recurrent liver cancer, surgical resection is still the preferred treatment plan, but affected by the location, size, distal metastasis and multi-center pathogenesis of liver cancer, only 10.4%\~31.0% can be surgically removed. In recent years, RFA has been widely used in liver cancer and recurrent liver cancer due to its unique advantages such as minimally invasive, simple operation, wide indication, reproducible, low cost, and accepted by patients, and has achieved satisfactory results. However, study found that because of the special location of recurrent liver cancer, its multi-center origin, and the characteristics of intrahepatic micrometastasis, it is often accompanied by microvascular tumor thrombus (MVI), which greatly increases the risk of liver cancer recurrence. Moreover, since the treatment of RFA can only be effective for the local detection of recurrent foci, and the effect of detecting small lesions is poor, there is a higher risk of recurrence. 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.

Whether combined radiotherapy and RFA treatment of liver cancer and recurrent liver cancer can further improve the clinical efficacy, there are few reports. Therefore, the short-term and long-term effects of radiotherapy combined with RFA in the treatment of liver cancer and recurrent liver cancer are studied to provide guidance for clinical treatment.

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Conditions studied

  • Hepatocellular Carcinoma
03

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 50 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

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.

04

Who can participate

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

Inclusion criteria

  1. According to the diagnosis and treatment of primary liver cancer (2017 version), patients diagnosed as primary liver cancer; 2, after surgery, CT or MRI and other related imaging examinations suggest recurrence of liver cancer and can not exclud micro lesions; 3. There is no history of systemic liver cancer chemotherapy and large vessel embolism; 4. Child-Pugh classification of liver function is grade A or B, and no xternal liver metastasisoccurs; 5, no serious cardiovascular or cerebrovascular diseases, renal or pulmonary organ disease; 6, no other malignant tumors; 7. all volunteered to participate in the study and signed informed consent.

Exclusion criteria

Exclusion Criteria:

1, with hepatic encephalopathy, refractory ascites and other serious complications; 2, combined with serious blood system diseases; 3, pregnant or lactating women; 4, during the period of receiving other treatment measures; Those who refused follow-up or follow-up data were not confirmed.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    RT&RFA

    Radiation: Radiofrequency ablation · Device: IMRT & SBRT

  • Active comparator
    RFA

    Radiation: Radiofrequency ablation

Interventions

  • RadiationRadiofrequency ablation

    Liver cancer radiofrequency ablation is a clinical treatment method that uses electrode needles to penetrate the skin and liver into the tumor and completely destroy the tumor through the principle of heat production to achieve the purpose of treating tumors.

  • DeviceIMRT & SBRT

    Tumor radiation therapy is a local treatment method using radiation to treat tumors. Radiation includes alpha, beta, and gamma rays produced by radioactive isotopes and x-rays, electron beams, proton beams, and other particle beams produced by various types of x-ray therapy machines or accelerators. Current mainstream radiotherapy technologies include stereotactic radiation therapy (SRT). Stereotactic radiation therapy (SRT) includes three-dimensional conformal radiation therapy (3DCRT) and three-dimensional conformal intensity modulated radiation therapy (IMRT).

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What researchers measure

Primary outcomes

  1. DFS

    Time frame: 2 years

Secondary outcomes

  1. OS

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • TaoBai
    Nanning, Guangxi 530000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2019, 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
NCT04202523
Lead sponsor
Guangxi Medical University
Responsible party
TaoBai (Researcher, Guangxi Medical University) — Principal investigator
First posted
Dec 17, 2019
Start date
Dec 1, 2019
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Dec 17, 2019

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 Dec 2019. You cannot join it, but the record below documents what was studied.

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