Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Neoadjuvant Radiotherapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatectomy alone

Patients in this group will receive hepatectomy alone.

Group Type EXPERIMENTAL

Hepatectomy alone

Intervention Type PROCEDURE

Patients in this group will receive hepatectomy alone.

Neoadjuvant radiotherapy plus hepatectomy

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

Group Type ACTIVE_COMPARATOR

Neoadjuvant radiotherapy

Intervention Type RADIATION

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

Interventions

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Hepatectomy alone

Patients in this group will receive hepatectomy alone.

Intervention Type PROCEDURE

Neoadjuvant radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes