NCT04202523

Combined Radiotherapy and Radiofrequency Ablation for Hepatocellular Carcinoma

Status unknown Phase 3 Last updated 17 December 2019

What this trial tests

Phase 3 trial testing Radiofrequency ablation in Hepatocellular Carcinoma in 50 participants. Status unknown.

Timeline

1 December 2019

Primary endpoint
1 December 2020

31 December 2020

Quick facts

Lead sponsor	Guangxi Medical University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 December 2019
Primary completion	1 December 2020
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• Radiofrequency ablation
• IMRT & SBRT

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Guangxi Medical University

Who can join

Eligibility, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Radiofrequency ablation: mechanisms and clinical applications.
   Wu J, Zhou Z, Huang Y, Deng X, et al · · 2024 · cited 24× · PMID 39359691 · DOI 10.1002/mco2.746