Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

NCT04025437 | Unknown Phase 2

• 1 other identifier: RT-HCC-PVTT
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.

  1 year

Secondary Outcomes (1)

• Recurrence-free survival

  1 year

Study Arms (2)

Hepatectomy alone

EXPERIMENTAL

Patients in this group will receive hepatectomy alone.

Procedure: Hepatectomy alone

Neoadjuvant radiotherapy plus hepatectomy

ACTIVE COMPARATOR

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

Radiation: Neoadjuvant radiotherapy

Interventions

Hepatectomy alone PROCEDURE

Patients in this group will receive hepatectomy alone.

Hepatectomy alone

Neoadjuvant radiotherapy RADIATION

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

Neoadjuvant radiotherapy plus hepatectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, 530021, China

Location

Related Publications (4)

• Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.

  PMID: 29543938 BACKGROUND

• He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250.

  PMID: 31070690 BACKGROUND

• Kudo M, Ueshima K, Yokosuka O, Ogasawara S, Obi S, Izumi N, Aikata H, Nagano H, Hatano E, Sasaki Y, Hino K, Kumada T, Yamamoto K, Imai Y, Iwadou S, Ogawa C, Okusaka T, Kanai F, Akazawa K, Yoshimura KI, Johnson P, Arai Y; SILIUS study group. Sorafenib plus low-dose cisplatin and fluorouracil hepatic arterial infusion chemotherapy versus sorafenib alone in patients with advanced hepatocellular carcinoma (SILIUS): a randomised, open label, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):424-432. doi: 10.1016/S2468-1253(18)30078-5. Epub 2018 Apr 7.

  PMID: 29631810 BACKGROUND

• Li N, Feng S, Xue J, Wei XB, Shi J, Guo WX, Lau WY, Wu MC, Cheng SQ, Meng Y. Hepatocellular carcinoma with main portal vein tumor thrombus: a comparative study comparing hepatectomy with or without neoadjuvant radiotherapy. HPB (Oxford). 2016 Jun;18(6):549-56. doi: 10.1016/j.hpb.2016.04.003. Epub 2016 May 7.

  PMID: 27317960 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics

Study Officials

• Wei-Zhong Tang, MD

  Cancer Hospital of Guangxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Neoadjuvant Radiotherapy

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 18, 2019
• Study Start: March 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)