Hepatocellular CarcinomaNCT06248528
Comparing the Prognosis of Patients With HCC and PVTT Treated With Surgery Versus Locoregional Therapy.
A study testing Liver resection and Locoregional therapy in people with Hepatocellular Carcinoma, run by Chen Xiaoping at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Liver resection and Locoregional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,076 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Wuhan, Hubei, 430000
About this study
Official title: 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.
Read the 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).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Liver resection, Locoregional therapy
- Keywords
- Hepatocellular carcinoma, Adjuvant therapy, Overall survival, Liver resection, Combined therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Patients in the intervention group received liver resection and postoperative adjuvant therapy
Locoregional therapyProcedure or surgery
Patients in the control group received locoregional therapy and systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| Liver resection-based group | Experimental | Patients in the liver resection-based group received adjuvant PD-1 inhibitors plus targeted drugs following liver resection. Receives: 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. Receives: Procedure: Locoregional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival was defined as the period from study inclusion until death from any cause.
Measured: 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
Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Dec 2019
- Primary completion31 Dec 2024
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaoping, Tongji Hospital
- Investigators
- WanGuang Zhang, Study director, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248528
- Sponsor's protocol ID
- CHALLENGE-01
- Status last verified
- Jul 2025
- First submitted
- 31 Jan 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06248528
- Acronym / sponsor ID
- CHALLENGE-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Adjuvant therapy, Overall survival, Liver resection, Combined therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,076 participants (actual)
- Lead sponsor
- Chen XiaopingUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver resection-based group | Experimental | Procedure: Liver resectionPatients in the liver resection-based group received adjuvant PD-1 inhibitors plus targeted drugs following liver resection. |
| Locoregional treatment-based group | Active comparator | Procedure: Locoregional therapyPatients in the locoregional treatment-based group received PD-1 inhibitors plus targeted drugs following locoregional therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver resectionPatients in the intervention group received liver resection and postoperative adjuvant therapy | Procedure or surgery | Liver resection-based group |
| Locoregional therapyPatients in the control group received locoregional therapy and systemic therapy | Procedure or surgery | Locoregional treatment-based group |
Primary outcome
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.
1 secondary outcome
Adverse effects
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WanGuang Zhang study director
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver resection and Locoregional therapy in people with Hepatocellular Carcinoma, run by Chen Xiaoping at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.