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Hepatocellular Carcinoma (HCC)NCT07077798

Adjuvant Sintilimab Plus Lenvatinib for HCC Characterized With VETC Following Liver Resection

A study testing Sintilimab and Lenvatinib in people with Hepatocellular Carcinoma (HCC), run by Wan-Guang Zhang.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Vessels that encapsulate tumor clusters (VETC) are a novel invasive metastatic factor in hepatocellular carcinoma (HCC), operating independently of the epithelial-mesenchyme transition (EMT). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Sintilimab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
No sites listed yet
Study dates
1 Aug 2025to 31 Dec 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

  • Age 18-75 years;
  • No previous local or systemic treatment for hepatocellular carcinoma;
  • Child-Pugh liver function score ≤ 7; ④ECOG PS 0-1; ⑤BCLC stage 0-C, underwent R0 resection and confirmed by pathology as hepatocellular carcinoma; ⑥No major systemic diseases, immunodeficiency diseases, etc.; ⑦CD34 immunohistochemical staining confirms the presence of VETC in the intratumoral vascular pattern (part or all of the field of view)

Who cannot join

  • Pregnant or breastfeeding women;
  • Recurrent HCC, distant metastasis or other systemic tumors;
  • Vascular invasion involving the mesenteric vein, main portal vein, hepatic vein or inferior vena cava;
  • History of gastrointestinal bleeding within the past 4 weeks;
  • Active infection; ⑥Other significant clinical and laboratory abnormalities that affect safety evaluation; ⑦Inability to follow the study protocol, receive treatment or follow-up as scheduled

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wanguang Zhang contact

13886195965

wgzhang@tjh.tjmu.edu.cn

About this study

Official title: Adjuvant Sintilimab Plus Lenvatinib for HCC Characterized With VETC Following Liver Resection: A Multicenter Prospective Study

Vessels that encapsulate tumor clusters (VETC) are a novel invasive metastatic factor in hepatocellular carcinoma (HCC), operating independently of the epithelial-mesenchyme transition (EMT). The presence of VETC is associated with a higher rate of postoperative recurrence in HCC patients, indicating a more aggressive biological behavior.Improving the prognosis for VETC-positive patients is a critical issue in clinical oncology.

Read the detailed description

Previous studies have established that VETC is a novel mode of metastasis, independent of EMT, and may be associated with immune suppression and poor prognosis. Numerous retrospective studies have found that patients with VETC positivity have higher rates of postoperative recurrence and distant metastasis. How to improve the surgical prognosis for VETC-positive patients remains to be explored. Currently, there are no published studies on how to improve the prognosis for this group of individuals. One of our unpublished retrospective studies found that treatment with PD-1 monoclonal antibodies does not effectively improve the prognosis for VETC-positive patients. However, the combination of PD-1 monoclonal antibodies with lenvatinib can effectively reduce postoperative recurrence and improve prognosis in VETC-positive patients. Therefore, we have designed this multicenter, randomized controlled trial to explore the efficacy and safety of lenvatinib in combination with sintilimab in VETC-positive HCC.

Being tested
Sintilimab, Lenvatinib
Keywords
HCC, VETC, Recurrence, PD-1, Lenvatinib
Medical subject headings
Carcinoma, Hepatocellular, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Patient receives first adjuvant sintilimab 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 8 cycles

  • LenvatinibDrug

    lenvatinib is initiated orally(12 mg for body weight \>= 60kg, 8 mg for body weight \< 60kg daily), 2-4 weeks postoperatively for 6 months.

Study groups in NCT07077798
Study groupRoleWhat they receive
Adjuvant groupExperimentalPatients in the adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.
Receives: Drug: Sintilimab; Drug: Lenvatinib
Control groupNo interventionThe control group patients did not receive any intervention and were actively monitored after surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    DFS defined as time to recurrence or death after surgery.

    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

Secondary outcomes (2)

  1. Overall survival

    OS defined as time to death from any cause after surgery.

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

  2. Adverse events

    The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0

    Measured: Baseline 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.

  1. First posted22 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077798
Sponsor's protocol ID
CHALLENGE-02
Status last verified
Jul 2025
First submitted
11 Jul 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Sintilimab and Lenvatinib in people with Hepatocellular Carcinoma (HCC), run by Wan-Guang Zhang.

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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Wanguang Zhang (13886195965, wgzhang@tjh.tjmu.edu.cn), or a site near the patient. 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?

On the ClinicalTrials.gov record for NCT07077798.

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 22 Jul 2025.

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