Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma

NCT03609268 | Unknown

• 1 other identifier: IR2018001025
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Hepatocellular Carcinoma; Microwave Ablation; Stereotactic Body Radiotherapy

Keywords

Recurrent Hepatocellular Carcinoma; Microwave ablation; Stereotactic body radiotherapy; Small liver cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Progression-free survival (PFS) was measured from the date of MWA or the first fraction of SBRT until the date of first progression (local or distant).

  From the date of MWA or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years.

Secondary Outcomes (2)

• local recurrence free survival

  From the date of MWA or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years

• overall survival

  From the date of MWA or the first fraction of SBRT until the date of death, assessed up to 3 years

Study Arms (2)

MWA

ACTIVE COMPARATOR

Patients receive microwave ablation (MWA)

Device: microwave ablation (MWA)

SBRT

EXPERIMENTAL

Patients receive stereotactic body radiotherapy (SBRT)

Radiation: stereotactic body radiotherapy (SBRT)

Interventions

microwave ablation (MWA) DEVICE

microwave ablation (MWA) for recurrent small liver cancer

MWA

stereotactic body radiotherapy (SBRT) RADIATION

stereotactic body radiotherapy (SBRT) for recurrent small liver cancer

SBRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and above.
• Clinical or pathological diagnosis of recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.)
• 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
• No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency
• 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.
• Men or women with fertility are willing to take contraceptive measures during the trial
• Eastern Cooperative Oncology Group score 0-1 points
• Expected survival period \> 3 months
• Voluntary participation and signing of informed consent

You may not qualify if:

• Patients who have undergone chemoradiation or targeted therapy for liver cancer
• Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points
• Total bilirubin \>70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
• Patients undergoing major surgery within 1 month of study initiation
• 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)
• Researchers consider it inappropriate to participate in the test

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Qichun Wei, MD,PhD

CONTACT

+86 571 87783521; qichun_wei@zju.edu.cn

Yongjie Shui, MM

CONTACT

+86 571 87783521; shui-yongjie@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 1, 2018
• Study Start: June 30, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

CN (1)