A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi

A Prospective, Randomized, Multicenter Study of Comparison of Transarterial Chemoembolization (TACE) Combination With and Without External- Beam Radiotherapy (EBRT) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi

The 1-year and 2-year overall survival rate (OS), local control rate (FFLP), disease-free progression time (PFS), and side effects were compared in patients with hepatocellular carcinoma limited to intrahepatic unresectable hepatocellular carcinoma with portal venous thrombosis combined with or without external radiotherapy, providing a basis for the development of relevant guidelines.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Procedure: TACE; Radiation: RT

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hosptial
      • Contact: jiazhou hou; Phone Number: +8602164041990 +8602164041990; Email: hou.jiazhou@zs-hosptial.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. confirmed by pathology or met the clinical diagnostic criteria of hepatocellular carcinoma.
2. after the joint consultation between the interventional department and the radiotherapy department, the patients who were considered to be interventional were considered. Meeting the following criteria: the tumor was confined to the liver (meeting the liver tolerance dose), and was diagnosed as type II or type III portal vein tumor thrombi according to chang's classification criteria, without extrahepatic metastasis. Number of tumors in liver parenchyma: less than or equal to 3. The main portal vein is not completely blocked or the compensatory collateral vessels of the portal vein are abundant although it is completely blocked.
3. patients who meet all the following criteria: Child-Pugh score ≤7, PLT>30×109/L, WBC>3×10^9/L/ANC>1.5×10^9/L,Hb>90g/L, Cr<2.0mg/dL.
4. ECOG score 0-2 points.
5. estimated survival time > 3 months.
6. age > 18.
7. sign the informed consent.

Exclusion Criteria:

1. patients with the following condition: the number of intrahepatic tumors >3 or total tumor diameter>15cm.
2. patients with signs of extrahepatic metastasis, including but not limited to inferior vena cava carcinoma thrombus, bone metastasis, brain metastasis or regional lymph node metastasis.
3. patients with West Haven standard grade III/IV hepatic encephalopathy or ascites.
4. patients with a history of malignancy other than primary HCC, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
5. patients with a history of upper abdominal radiotherapy.
6. in the radiotherapy plan, patients who failed to follow the radiation dose limit of important organs, including those whose normal liver tissue was less than 700 ml in the radiotherapy plan.
7. screening patients who have received other study drugs within 4 weeks prior to the start of the visit.
8. screening: patients who had received treatment for other local or systemic hepatocellular carcinoma within 4 weeks before the visit.
9. patients with significant concurrent diseases.
10. lactating or pregnant female patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TACE	Procedure: TACE; transarterial chemoembolization (TACE)
EXPERIMENTAL: TACE+RT	Procedure: TACE; transarterial chemoembolization (TACE); Radiation: RT; external- beam radiotherapy (EBRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2019
• Primary Completion (ANTICIPATED): April 23, 2021
• Study Completion (ANTICIPATED): April 23, 2022

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 4, 2019
• First Posted (ACTUAL): May 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: PVT/RT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No