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Combined Radiotherapy and Radiofrequency Ablation for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiofrequency ablation
IMRT & SBRT
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

  • TaoBaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RT&RFA

RFA

Arm Description

Outcomes

Primary Outcome Measures

DFS

Secondary Outcome Measures

OS

Full Information

First Posted
December 16, 2019
Last Updated
December 16, 2019
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04202523
Brief Title
Combined Radiotherapy and Radiofrequency Ablation for Hepatocellular Carcinoma
Official Title
Study of Combined Radiotherapy and Radiofrequency Ablation for Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RT&RFA
Arm Type
Experimental
Arm Title
RFA
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
Radiofrequency ablation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IMRT & SBRT
Intervention Description
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).
Primary Outcome Measure Information:
Title
DFS
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Facility Information:
Facility Name
TaoBai
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Bai, MD
Phone
+86 13878862632
Email
baitao@gxmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Combined Radiotherapy and Radiofrequency Ablation for Hepatocellular Carcinoma

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