NCT06248528

Brief Summary

Hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. Barcelona clinical liver cancer stage C. For the treatment of PVTT, there are differences between Eastern and Western guidelines, with systemic drugs being the standard of care in Western countries, while surgical treatment is often actively practiced in the Asia-Pacific region. More research is needed to explore the differences between these two approaches.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,076

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
9mo left

Started Dec 2019

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2019Jan 2027

Study Start

First participant enrolled

December 1, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

5.1 years

First QC Date

January 31, 2024

Last Update Submit

July 11, 2025

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaAdjuvant therapyOverall survivalLiver resectionCombined therapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival was defined as the period from study inclusion until death from any cause.

    From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months.

Secondary Outcomes (1)

  • Adverse effects

    12 months

Study Arms (2)

Liver resection-based group

EXPERIMENTAL

Patients in the liver resection-based group received adjuvant PD-1 inhibitors plus targeted drugs following liver resection.

Procedure: Liver resection

Locoregional treatment-based group

ACTIVE COMPARATOR

Patients in the locoregional treatment-based group received PD-1 inhibitors plus targeted drugs following locoregional therapy.

Procedure: Locoregional therapy

Interventions

Liver resectionPROCEDURE

Patients in the intervention group received liver resection and postoperative adjuvant therapy

Liver resection-based group
Locoregional therapyPROCEDURE

Patients in the control group received locoregional therapy and systemic therapy

Locoregional treatment-based group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75 years
  • Pathological type is HCC, and with PVTT
  • No extrahepatic HCC
  • Eastern Cooperative Oncology Group (ECOG) performing status of 0-1 and Child-Pugh grade A for the liver resection group
  • ECOG performing status of 0-2 and Child-Pugh grade A-B for the locoregional-based group
  • Adequate hematologic and organ function

You may not qualify if:

  • Any history of other malignant tumors or recurrent HCC
  • Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
  • Any persistent serious liver resection or locoregional therapy-related complications
  • Esophageal and/or gastric variceal bleeding within 6 months
  • Inability or refusal to comply with the treatment and monitoring
  • Participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • WanGuang Zhang

    Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 8, 2024

Study Start

December 1, 2019

Primary Completion

December 31, 2024

Study Completion (Estimated)

January 31, 2027

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)