Comparison of Efficacy in SBRT of Large HCC With or Without TACE

NCT04512846 | Recruiting

• 1 other identifier: large HCC with/without TACE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) 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

Large HCC Patients; Stereotactic Body Radiation Therapy; Transcatheter Arterial Chemoembolization

Keywords

CyberKnife; SBRT; large HCC; prognosis

Outcome Measures

Primary Outcomes (3)

• Overall survival time

  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 time

  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 time

  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)

CK-SBRT with TACE group

The hepatocellular carcinoma patients (5-10cm）who received SBRT with TACE.

CK-SBRT group

The hepatocellular carcinoma patients (5-10cm）who received SBRT alone.

Eligibility Criteria

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

Study Population

The large HCC patients who receive SBRT with or without TACE.

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 were 5-10cm;
• 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)

Beijing 302 hospital

Beijing, 100039, China

RECRUITING

Related Publications (3)

• 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

• Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.

  PMID: 20879569 RESULT

Central Study Contacts

Jing Sun

CONTACT

+8613718681094; 519299998@qq.com

Xuezhang Duan

CONTACT

+8613621386161; duanxuezhang2006@163.com

Study Design

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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2023
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 27, 2023

Record last verified: 2023-03

Locations

CN (1)