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HCC - Hepatocellular CarcinomaPhase 2NCT07518706

Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin

A Phase 2 study testing Tislelizumab and Lenvatinib in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

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

Official record
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Trial summary

Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HCC - Hepatocellular Carcinoma
What is being tested?
Tislelizumab and Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
30 Apr 2026to 30 Apr 2029
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily participates in this study and provides written informed consent.
  • Age ≥18 years at the time of consent; male or female.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
  • Child-Pugh class A hepatic function.
  • Histologically/cytologically confirmed, or clinically diagnosed according to accepted diagnostic criteria, primary hepatocellular carcinoma (HCC), with a single tumor measuring 2-5 cm in greatest diameter (CNLC stage IA).
  • At enrollment, the lesion meets the criteria for surgically resectable disease per the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition); and an anticipated narrow surgical margin (resection margin <1 cm) is expected due to tumor size and/or location, including any of the following:
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  • Lesion adjacent to the main trunk of the portal vein or first-order branches;
  • Lesion adjacent to the inferior vena cava or the root of the hepatic veins;
  • Lesion located in the caudate lobe.
  • No prior local or systemic antitumor therapy for HCC.
  • At least one measurable lesion per RECIST v1.1.
  • Adequate function of major organs within 14 days prior to initiation of study treatment, as defined below:
  • Hematology (no blood transfusion within 14 days before screening; no granulocyte colony-stimulating factor [G-CSF] use; and no pharmacologic correction except for hemoglobin): absolute neutrophil count (ANC) ≥1.5×10^9/L; platelets ≥75×10^9/L; hemoglobin ≥90 g/L.
  • Serum chemistry (no albumin infusion within 14 days before screening): serum albumin ≥29 g/L; total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤5×ULN; serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) >50 mL/min (Cockcroft-Gault formula below).
  • Male: CrCl = (140 - age) × weight / (72 × serum Cr) Female: CrCl = [(140 - age) × weight / (72 × serum Cr)] × 0.85 Weight in kg; serum Cr in mg/dL. (3) International normalized ratio (INR) ≤2.3, or prothrombin time (PT) prolongation ≤6 seconds above the institutional normal control.
  • Urine protein <2+; if urine protein is ≥2+, a 24-hour urine protein quantification may be performed, and patients with 24-hour urine protein <1.0 g are eligible.
  • 10. Viral hepatitis management:
  • For patients with active hepatitis B virus (HBV) infection: HBV DNA must be <500 IU/mL (if the site reports in copies/mL only, <2,500 copies/mL), and the patient must have received anti-HBV therapy for at least 14 days before initiation of study treatment (per local standard of care, e.g., entecavir) and be willing to continue antiviral therapy throughout the study.
  • Patients who are hepatitis C virus (HCV) RNA positive must receive antiviral therapy per local standard treatment guidelines, and liver function abnormalities must be no greater than CTCAE Grade 1.
  • 11. Contraception: Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 6 months after the last dose; a negative serum or urine pregnancy test within 7 days prior to enrollment is required; women must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 6 months after the end of the study.
  • 12. The participant is able and willing to comply with the protocol requirements and follow-up schedule.

Who cannot join

  • Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; any other active malignancy concurrent with HCC or within the past 5 years, except for definitively treated localized tumors (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ).
  • Planned or prior solid-organ transplantation or allogeneic bone marrow transplantation (corneal transplantation is allowed).
  • Known hypersensitivity to macromolecular protein products, or known allergy to any excipients of tislelizumab.
  • Any active autoimmune disease or a history of autoimmune disease.
  • Use of immunosuppressive agents, or systemic or absorbable topical corticosteroid therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent), that is ongoing within 2 weeks prior to enrollment.
  • Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis, thoracentesis, or drainage.
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  • Uncontrolled clinically significant cardiac symptoms or disease, including:
  • New York Heart Association (NYHA) class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
  • 8. Current (within the past 3 months) gastrointestinal conditions including esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or active bleeding from unresected tumor(s), or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation.
  • 9. History or current evidence of severe bleeding (blood loss >30 mL within the past 3 months), hemoptysis (>5 mL of fresh blood within the past 4 weeks), or a thromboembolic event within the past 12 months (including stroke and/or transient ischemic attack).
  • 10. Active infection, or fever of unknown origin >38.5°C during screening or prior to the first dose (fever judged by the investigator to be tumor-related is allowed).
  • 11. Congenital or acquired immunodeficiency, such as HIV infection. 12. Receipt of a live attenuated vaccine within 4 weeks prior to administration of study treatment.
  • 13. Use of traditional Chinese medicine with antitumor indications within 2 weeks prior to the first dose, or receipt of medications with immunomodulatory effects within 2 weeks prior to the first dose.
  • 14. Known history of abuse of psychoactive drugs, alcoholism, or illicit drug use.
  • 15. Ongoing treatment-related serious adverse events prior to enrollment in this study.
  • 16. Any condition that, in the investigator's opinion, makes the participant unsuitable for the study, including factors that may necessitate premature discontinuation (e.g., other serious diseases [including psychiatric disorders] requiring concomitant treatment, severe laboratory abnormalities, or family/social circumstances that may compromise participant safety or interfere with data and specimen collection).

About this study

Official title: A Phase II Study Comparing Neoadjuvant Tislelizumab Plus Lenvatinib Followed by Surgery Versus Surgery Alone in Patients With Stage Ia Hepatocellular Carcinoma and an Anticipated Narrow Surgical Margin

Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.

Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • TislelizumabDrug

    Tislelizumab, 200mg, IV, q3w. Treatment will be given in 3-week cycles for a total of 2 cycles.

  • LenvatinibDrug

    Lenvatinib, 8mg for BW<60kg or 12mg for BW≥60kg, PO, qd. Treatment will be given in 3-week cycles for a total of 2 cycles.

Study groups in NCT07518706
Study groupRoleWhat they receive
Arm ANo interventionThe Surgery-alone Group: the patients will receive surgery alone after enrollment and randomization.
Arm BExperimentalThe Neoadjuvant Treatment Group: the patients will receive 2 cycles of neoadjuvant tislelizumab plus lenvatinib after enrollment and randomization and receive surgery in sequence.
Receives: Drug: Tislelizumab; Drug: Lenvatinib

What is being measured

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

  1. 1-year RFS

    Measured: 1 year after surgery

Secondary outcomes (9)

  1. ORR

    Measured: 6 weeks after randomization

  2. DCR

    Measured: 6 weeks after randomization

  3. MPR

    Measured: 10 weeks after randomization

  4. Incidence of Microvascular invasion (MVI)

    Measured: 10 weeks after randomization

  5. 1-year EFS

    Measured: 1 year after randomization

  6. RFS

    Measured: 36 months after randomization

  7. EFS

    Measured: 36 months after randomization

  8. OS

    Measured: 36 months after randomization

  9. Incidence of treatment-related adverse events(graded per CTCAE v5.0)

    Measured: 10 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Apr 2029 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07518706
Sponsor's protocol ID
2508012438
Status last verified
Apr 2026
First submitted
1 Apr 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in the primary publication (including data dictionaries) will be made available upon reasonable request to qualified researchers. Data will be available beginning 12 months after article publication, with no end date. Requestors will need to sign a data access agreement and obtain approval from an institutional review board.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and Lenvatinib in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

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 21 inclusion and 16 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 9 Apr 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

1-year RFS (time frame: 1 year after surgery). 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 NCT07518706.

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 9 Apr 2026.

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