Comparison of Efficacy in SBRT of HCC ≤5 cm With or Without TACE

Stereotactic Body Radiation Therapy Clinical Trial

Official title:

Comparison of Efficacy in Stereotactic Body Radiation Therapy (SBRT) of Hepatocellular Carcinoma ≤5 cm With or Without Transcatheter Arterial Chemoembolization (TACE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161287
• Other study ID #: JingSun
• Status: Recruiting
• Start date: October 11, 2019
• Est. completion date: January 11, 2025

Study information

• Verified date: March 2023
• Source: Beijing 302 Hospital
• Contact: Jing Sun, Master
• Phone: +8613718681094
• Email: 519299998[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to compare efficacy and adverse reactions of hepatocellular carcinoma participants (≤5cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: January 11, 2025
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology

• single lesion and longest tumor diameter = 5.0 cm

• CP-A or B classification

• Eastern Cooperative Oncology Group (ECOG) score 0-1;

• distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm

• unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.

• rejecting other therapies such as resection, liver transplantation, etc.

• platelet count=50 × 109/L, white blood count=1.5 × 109/L

• patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Exclusion Criteria:

• tumor thrombus

• lymph node involvement

• extrahepatic metastasis

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Small Hepatocellular Carcinoma
• Stereotactic Body Radiation Therapy
• Transcatheter Arterial Chemoembolization

Intervention

Procedure:
• transcatheter arterial chemoembolization
The hepatocellular carcinoma patients (=5cm)who received SBRT are devided into two groups: with TACE and SBRT alone.

Locations

Country	Name	City	State
China	The Fifth Medical Center of PLA General Hospital (Beijing 302 hospital)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Su TS, Lu HZ, Cheng T, Zhou Y, Huang Y, Gao YC, Tang MY, Jiang HY, Lian ZP, Hou EC, Liang P. Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unre — View Citation

Sun J, Zhang T, Wang J, Li W, Zhang A, He W, Zhang D, Li D, Ding J, Duan X. Biologically effective dose (BED) of stereotactic body radiation therapy (SBRT) was an important factor of therapeutic efficacy in patients with hepatocellular carcinoma (</=5 cm) — View Citation

Takayasu K, Arii S, Kudo M, Ichida T, Matsui O, Izumi N, Matsuyama Y, Sakamoto M, Nakashima O, Ku Y, Kokudo N, Makuuchi M. Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese — View Citation

Wong TC, Chiang CL, Lee AS, Lee VH, Yeung CS, Ho CH, Cheung TT, Ng KK, Chok SH, Chan AC, Dai WC, Wong FC, Luk MY, Leung TW, Lo CM. Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatoc — View Citation

Zhang T, Sun J, He W, Li H, Piao J, Xu H, Duan X. Stereotactic body radiation therapy as an effective and safe treatment for small hepatocellular carcinoma. BMC Cancer. 2018 Apr 20;18(1):451. doi: 10.1186/s12885-018-4359-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rates	OS is calculated starting from the date of SBRT to the date of the final follow-up or demise of the patients.	From date of randomization until the date of death from any cause, assessed up to 36 months
Primary	Progression-free survival rates	PFS is estimated starting from the date of SBRT to the date of disease progression or patient death.	From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 36 months
Primary	Local control rates	LC is defined starting from the date of SBRT to the date of treated-lesion progression or patient death.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary	Radiation-induced liver injury rates		From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.
Secondary	Adverse reaction		From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.