Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

Study Overview
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Hepatectomy alone
* Radiation: Neoadjuvant radiotherapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Neoadjuvant Radiotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatectomy alone<br>Patients in this group will receive hepatectomy alone. | Procedure: Hepatectomy alone<br>* Patients in this group will receive hepatectomy alone.<br>|
| Active Comparator: Neoadjuvant radiotherapy plus hepatectomy<br>Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy. | Radiation: Neoadjuvant radiotherapy<br>* Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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