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

NCT04161287 | Unknown DMC

• 1 other identifier: JingSun
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Hepatocellular Carcinoma; Stereotactic Body Radiation Therapy; Transcatheter Arterial Chemoembolization

Keywords

CyberKnife; SBRT; TACE; prognosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Radiation-induced liver injury rates

  From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

• Adverse reaction

  From the date of radiotherapy completion until the 4 months after therapy,up to 6 months.

Study Arms (2)

SBRT with TACE

Procedure: transcatheter arterial chemoembolization

SBRT alone

Interventions

transcatheter arterial chemoembolization PROCEDURE

The hepatocellular carcinoma patients (≤5cm）who received SBRT are devided into two groups: with TACE and SBRT alone.

SBRT with TACE

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hepatocellular carcinoma patients whose lesion diameter ≤ 5.0 cm

You may qualify if:

• 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.

You may not qualify if:

• tumor thrombus
• lymph node involvement
• extrahepatic metastasis

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The Fifth Medical Center of PLA General Hospital (Beijing 302 hospital)

Beijing, 100039, China

RECRUITING

Related Publications (5)

• 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). BMC Cancer. 2019 Aug 28;19(1):846. doi: 10.1186/s12885-019-6063-9.

  PMID: 31455251 RESULT

• 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.

  PMID: 29678159 RESULT

• 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 unresectable hepatocellular carcinoma >5 cm. BMC Cancer. 2016 Nov 3;16(1):834. doi: 10.1186/s12885-016-2894-9.

  PMID: 27809890 RESULT

• 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 hepatocellular carcinoma: A propensity score matched analysis. Surg Oncol. 2019 Mar;28:228-235. doi: 10.1016/j.suronc.2019.01.006. Epub 2019 Jan 29.

  PMID: 30851906 RESULT

• 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 guidelines. J Hepatol. 2012 Apr;56(4):886-92. doi: 10.1016/j.jhep.2011.10.021. Epub 2011 Dec 13.

  PMID: 22173160 RESULT

Study Officials

• Xuezhang Duan, PH.D

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Sun, Master

CONTACT

+8613718681094; 519299998@qq.com

Xuezhang Duan, PH.D

CONTACT

8613621386161; duanxuezhang2006@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 13, 2019
• Study Start: October 11, 2019
• Primary Completion: December 11, 2023
• Study Completion: January 11, 2025
• Last Updated: February 2, 2024

Record last verified: 2023-03

Locations

CN (1)