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Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

G

Guangxi Medical University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Hepatectomy alone
Radiation: Neoadjuvant radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04025437
RT-HCC-PVTT

Details and patient eligibility

About

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.

Enrollment

214 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

214 participants in 2 patient groups

Hepatectomy alone
Experimental group
Description:
Patients in this group will receive hepatectomy alone.
Treatment:
Procedure: Hepatectomy alone
Neoadjuvant radiotherapy plus hepatectomy
Active Comparator group
Description:
Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
Treatment:
Radiation: Neoadjuvant radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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