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

HepatoCellular Carcinoma Clinical Trial

— RHCC:BCLC-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02678806
• Other study ID #: GDWTaoBai
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2018
• Source: Guangxi Medical University
• Contact: Tao Bai, MD
• Phone: +86 13878862632
• Email: 25859373[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• HepatoCellular Carcinoma

Intervention

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

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.

Locations

Country	Name	City	State
China	TaoBai	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5years