Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma

NCT ID: NCT03609268

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2021-05-31

Brief Summary

The prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.

Detailed Description

Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, group B patients receive SBRT. The 3-year progression free survival, 3-year local recurrence free survival, 3-year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to MWA.

Conditions

Recurrent Hepatocellular Carcinoma; Microwave Ablation; Stereotactic Body Radiotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MWA

Patients receive microwave ablation (MWA)

Group Type: ACTIVE_COMPARATOR

microwave ablation (MWA)

Intervention Type: DEVICE

microwave ablation (MWA) for recurrent small liver cancer

SBRT

Patients receive stereotactic body radiotherapy (SBRT)

Group Type: EXPERIMENTAL

stereotactic body radiotherapy (SBRT)

Intervention Type: RADIATION

stereotactic body radiotherapy (SBRT) for recurrent small liver cancer

Interventions

microwave ablation (MWA)

microwave ablation (MWA) for recurrent small liver cancer

Intervention Type: DEVICE

stereotactic body radiotherapy (SBRT)

stereotactic body radiotherapy (SBRT) for recurrent small liver cancer

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. 18 years old and above.

2. Clinical or pathological diagnosis of recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.)

3. Small hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis

4. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency

5. The neutrophil count is at least 1.0*10^9/ml, and the platelet count is at least 50*10^9/ml. Hemoglobin is at least 80g/L.

6. Men or women with fertility are willing to take contraceptive measures during the trial

7. Eastern Cooperative Oncology Group score 0-1 points

8. Expected survival period > 3 months

9. Voluntary participation and signing of informed consent

Exclusion Criteria

1. Patients who have undergone chemoradiation or targeted therapy for liver cancer

2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points

3. Total bilirubin >70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.

4. Patients undergoing major surgery within 1 month of study initiation

5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years)

6. Researchers consider it inappropriate to participate in the test

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qichun Wei, MD,PhD

Role: CONTACT

qichun_wei@zju.edu.cn

+86 571 87783521

Yongjie Shui, MM

Role: CONTACT

shui-yongjie@zju.edu.cn

+86 571 87783521

Facility Contacts

Qichun Wei, MD,PhD

Role: primary

qichun_wei@zju.edu.cn

+86 571 87783521

Yongjie Shui, MM

Role: backup

shui-yongjie@zju.edu.cn

+86 571 87783521

Other Identifiers

IR2018001025

Identifier Type: -

Identifier Source: org_study_id