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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03609268
Other study ID # IR2018001025
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2018
Est. completion date May 31, 2021

Study information

Verified date July 2018
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Qichun Wei, MD,PhD
Phone +86 571 87783521
Email qichun_wei@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
microwave ablation (MWA)
microwave ablation (MWA) for recurrent small liver cancer
Radiation:
stereotactic body radiotherapy (SBRT)
stereotactic body radiotherapy (SBRT) for recurrent small liver cancer

Locations

Country Name City State
China the second affiliated hospital of Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 local recurrence free survival Local recurrence free survival (LRFS) was measured from the date of MWA or the first fraction of SBRT until the date of local recurrence. From the date of MWA or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
Secondary overall survival Overall survival (OS) was measured from the date of MWA or the first fraction of SBRT until the date of death. From the date of MWA or the first fraction of SBRT until the date of death, assessed up to 3 years
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