Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04823715
Acronym
TACE-hypoRT
Enrollment
163
Registered
2021-04-01
Start date
2020-10-15
Completion date
2021-01-15
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-metastatic Hepatocellular Carcinoma

Keywords

Liver neoplasms, Carcinoma, Hepatocellular, Radiation therapy, TACE, Transarterial Chemoembolization

Brief summary

Patients with non-metastatic unresectable hepatocellular carcinoma

Interventions

OTHERTACE + 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.

PROCEDURESurgical resection

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease-free survival of the patient after start of treatmentWithin 10 years after the treatment (surgical resection or TACE)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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026