HCCNCT06253364
VETC is an Effective Marker for Postoperative Adjuvant Immunotherapy
An observational study of HCC and Recurrence, run by Chen Xiaoping at 1 site in China.
Trial summary
Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. However, it is not clear how the surgical prognosis of VETC-positive patients can be improved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC, Recurrence
- What is being tested?
- PD-1 monoclonal antibody and lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 462 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients who met the inclusion and exclusion criteria were retrospectively collected for this study.
Who may be able to join
- Underwent radical hepatectomy
- No preoperative treatment
- Pathological confirmed HCC
- High-risk recurrent HCC
- Not receiving any adjuvant therapy or receiving adjuvant therapy with PD-1 monotherapy or receiving adjuvant therapy with PD-1 monotherapy in combination with Lenvatinib after surgery
Who cannot join
- Macrovascular invasion
- No available wax blocks
- No complete clinical information
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Robust Biomarker of Aggressive HCC and the Response for Adjuvant PD-1 Inhibitors or Combined TKIs Following Liver Resection: Vessels That Encapsulate Tumor Clusters
Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. However, it is not clear how the surgical prognosis of VETC-positive patients can be improved.
Read the detailed description
Previous studies have identified VETC as a new metastatic pattern independent of EMT that may be associated with immunosuppression as well as poor prognosis. Multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive patients. How to improve surgical prognosis in VETC-positive patients needs to be explored. There is no consensus on postoperative adjuvant therapy for HCC. In recent years, adjuvant immunotherapy (sintilimab) and adjuvant immunotherapy combined with targeted therapy (T+A) have been shown to be effective in improving the surgical prognosis. Therefore, the investigators retrospectively collected three surgical resection cohorts, the surgical resection alone group, the postoperative adjuvant PD-1 monotherapy group, and the postoperative adjuvant PD-1 monotherapy combined with Lenvatinib group, to compare these postoperative adjuvant therapies in a subgroup of VETC patients.
- Conditions
- HCC, Recurrence
- Being tested
- PD-1 monoclonal antibody and lenvatinib
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 monoclonal antibody and lenvatinibDrug
Adjuvant PD-1 group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles.
Adjuvant PD-1 plus Lenvatinib group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV 21 days for 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Liver resection group | No adjuvant therapy after hepatectomy. | |
| Adjuvant PD-1 group | Adjuvant therapy with PD-1 monoclonal antibody after hepatectomy Receives: Drug: PD-1 monoclonal antibody and lenvatinib | |
| Adjuvant PD-1 plus Lenvatinib group | Adjuvant therapy with PD-1 monoclonal antibody combined with lenvatinib after hepatectomy. Receives: Drug: PD-1 monoclonal antibody and lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease -free survival
Disease-free survival was defined as defined as the time from enrollment to diagnosis of recurrence or death from any cause.
Measured: From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jan 2019
- Primary completion30 Jun 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaoping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253364
- Sponsor's protocol ID
- Biomarker1
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Robust Biomarker of Aggressive HCC and the Response for Adjuvant PD-1 Inhibitors or Combined TKIs Following Liver Resection: Vessels That Encapsulate Tumor Clusters
- ClinicalTrials.gov ID
- NCT06253364
- Acronym / sponsor ID
- Biomarker1
- Conditions
- HCC, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Chen XiaopingUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 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.
Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. However, it is not clear how the surgical prognosis of VETC-positive patients can be improved.
Detailed description
Previous studies have identified VETC as a new metastatic pattern independent of EMT that may be associated with immunosuppression as well as poor prognosis. Multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive patients. How to improve surgical prognosis in VETC-positive patients needs to be explored. There is no consensus on postoperative adjuvant therapy for HCC. In recent years, adjuvant immunotherapy (sintilimab) and adjuvant immunotherapy combined with targeted therapy (T+A) have been shown to be effective in improving the surgical prognosis. Therefore, the investigators retrospectively collected three surgical resection cohorts, the surgical resection alone group, the postoperative adjuvant PD-1 monotherapy group, and the postoperative adjuvant PD-1 monotherapy combined with Lenvatinib group, to compare these postoperative adjuvant therapies in a subgroup of VETC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liver resection group | – | –No adjuvant therapy after hepatectomy. |
| Adjuvant PD-1 group | – | Drug: PD-1 monoclonal antibody and lenvatinibAdjuvant therapy with PD-1 monoclonal antibody after hepatectomy |
| Adjuvant PD-1 plus Lenvatinib group | – | Drug: PD-1 monoclonal antibody and lenvatinibAdjuvant therapy with PD-1 monoclonal antibody combined with lenvatinib after hepatectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who met the inclusion and exclusion criteria were retrospectively collected for this study.
Key inclusion criteria (5 listed)
- Underwent radical hepatectomy
- No preoperative treatment
- Pathological confirmed HCC
- High-risk recurrent HCC
- Not receiving any adjuvant therapy or receiving adjuvant therapy with PD-1 monotherapy or receiving adjuvant therapy with PD-1 monotherapy in combination with Lenvatinib after surgery
Key exclusion criteria (3 listed)
- Macrovascular invasion
- No available wax blocks
- No complete clinical information
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 |
|---|---|---|
| PD-1 monoclonal antibody and lenvatinibAdjuvant PD-1 group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles. Adjuvant PD-1 plus Lenvatinib group: Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV 21 days for 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months. | Drug | Adjuvant PD-1 group, Adjuvant PD-1 plus Lenvatinib group |
Primary outcome
Disease -free survival
Time frame: From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months
Disease-free survival was defined as defined as the time from enrollment to diagnosis of recurrence or death from any cause.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC and Recurrence, 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 13 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease -free survival (time frame: From date of include in this research until the date of first documented recurrence or 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 13 Mar 2024.