Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.

July 11, 2025 updated by: Chen Xiaoping

To Compare the Survival Differences in Patients With HCC and Portal Vein Tumor Thrombosis Treated With Liver Resection-based Therapy Versus Locoregional-based Therapy: a Prospective Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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. In recent years, breakthroughs have been made in the treatment of advanced HCC, and systemic drug combinations such as PD-1 inhibitors combined with targeted therapies, and local area therapy combined with systemic therapy have shown excellent anti-tumor effects. Postoperative adjuvant therapy is also advancing, and the combination of adjuvant systemic medications for patients after PVTT has also been effective in reducing postoperative recurrence. Which approach is better for PVTT patients needs to be explored in depth.

We launched the CHALLENGE-01 study in October 2023. The study consists of two phases: the first phase involves retrospective data collection from 2019 to 2023 and prospective follow-up of survival information. Specifically, the liver resection+ PD-1 inhibitor + lenvatinib (LRPL) cohort included 225 cases, the TACE + PD-1 inhibitor + lenvatinib (TPL) cohort included 205 cases, and the surgery-only treatment cohort included 200 cases as an additional control group. Data analysis from the first phase of the study showed that the median follow-up times for the LRPL and TPL cohorts were 31.6 months and 22.5 months, respectively. Based on retrospective cohort data, we calculated the sample size required for the prospective study (446) and formally initiated the second-phase prospective clinical trial in January 2024. The study completed the required enrollment from nine centers in China by December 31, 2024, but has not yet reached the primary endpoint (OS).

Study Type

Interventional

Enrollment (Actual)

1076

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver resection-based group
Patients in the liver resection-based group received adjuvant PD-1 inhibitors plus targeted drugs following liver resection.
Procedure: Liver resection
Patients in the intervention group received liver resection and postoperative adjuvant therapy
Active Comparator: Locoregional treatment-based group
Patients in the locoregional treatment-based group received PD-1 inhibitors plus targeted drugs following locoregional therapy.
Procedure: Locoregional therapy
Patients in the control group received locoregional therapy and systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 12 months
Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Xiaoping

Investigators

  • Study Director: WanGuang Zhang, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHALLENGE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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