Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

Neoadjuvant Radiotherapy for Patients With Hepatocellular Carcinoma Involving Type I Portal Vein Tumor Thrombus

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04025437

Enrollment

214

Registered

2019-07-18

Start date

2019-03-01

Completion date

2021-12-31

Last updated

2019-09-04

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

Conditions

Hepatocellular Carcinoma

Brief summary

The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.

Interventions

PROCEDUREHepatectomy alone

Patients in this group will receive hepatectomy alone.

RADIATIONNeoadjuvant radiotherapy

Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Neoadjuvant Radiotherapy

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 18-75 years; * Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus; * Child-Pugh A or B (7 score) liver function; * With more than 3 months expected survival; * The volume of residual liver more than 30%; * Patients agree to take part in.

Exclusion criteria

* Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus * Previous history of epigastric radiotherapy * With extrahepatic metastasis * With radiotherapy contraindication; * Pregnant woman or sucking period; * With repture tumor; * With other cancer in previous five years; * With chemothrapy, target therapy or immunosuppressive drugs therapy.

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	1 year	From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.

Secondary

Measure	Time frame	Description
Recurrence-free survival	1 year	From the date of hepatectomy to HCC recurrence or the end of follow-up.

Countries

China

Outcome results

None listed

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