Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW Comparison

Non-metastatic Hepatocellular Carcinoma Clinical Trial

— TACE-hypoRT  

Official title:

Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823715
• Other study ID #: 249
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: March 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with non-metastatic unresectable hepatocellular carcinoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years of age

• ECOG 0-2

• Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients

• Child-Pugh class A

• Absence of truncular or lobar portal vein invasion, or suprahepatic vein invasion

Exclusion Criteria:

• Uncontrolled replication of hepatitis B virus

• Transplanted liver

• Previous abdominal irradiation

• Previous treatment of HCC with systemic therapy, or with surgical resection in the 2 previous years

• Metastatic illness

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Non-metastatic Hepatocellular Carcinoma

Intervention

Other:
• TACE + hypofractionated EBRT
One cure of doxorubicin or DC Beads transarterial chemoembolization by a highly experienced interventional radiologist, followed 1 to 4 weeks later by hypofractionated external beam radiation therapy up to a total dose of 45-60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks.

Procedure:
• Surgical resection
Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon

Locations

Country	Name	City	State
France	Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival of the patient after start of treatment	Disease-Free Survival (DFS) defined as the time (in months) between the treatment (surgical resection or TACE) and the diagnostic of local, locoregional or distant recurrence, or date of death from any cause; patients who are alive or lost to follow-up at the time of the analysis will be censored on the last follow-up date; patients who have received a liver transplant for non-carcinologic reason will be censored on the date of transplantation.	Within 10 years after the treatment (surgical resection or TACE)