HCC - Hepatocellular CarcinomaPhase 3Neo-LENTISNCT07475026
A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence
A Phase 3 study testing Tislelizumab and Lenvatinib in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 198 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2026to 31 Dec 2030
- Phase
- Phase 3
- 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
- Voluntarily participates in this study and provides written informed consent.
- Aged 18 to 75 years, inclusive; male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Child-Pugh class A liver function.
- China Liver Cancer (CNLC) stage Ib to IIa.
- Histologically/cytologically confirmed HCC, or clinically diagnosed primary hepatocellular carcinoma according to accepted diagnostic criteria, with lesions meeting the criteria for surgical resection as defined in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition).
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- At least one measurable lesion per RECIST v1.1.
- Estimated life expectancy ≥ 6 months.
- Adequate major organ function as defined below, without transfusion of any blood components or use of hematopoietic growth factors within 14 days prior to assessment:
- Hematology
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 5.6 mmol/L (9 g/dL)
- Hepatic and renal function
- Serum creatinine (SCr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
- Total bilirubin (TBIL) ≤ 1.5 × ULN
- AST and/or ALT ≤ 2.5 × ULN
- Urine protein < 2+; if urine protein is ≥ 2+, 24-hour urine protein must be ≤ 1 g.
- Adequate coagulation function, with no active bleeding and no thrombotic disease:
- International normalized ratio (INR) ≤ 1.5 × ULN
- Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- Prothrombin time (PT) ≤ 1.5 × ULN
- Contraception requirements:
- 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; must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.
- Men with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of study treatment.
- Demonstrates good compliance and is able/willing to complete required follow-up.
Who cannot join
- Prior antitumor therapy for the current HCC, including radiotherapy, chemotherapy, concurrent chemoradiotherapy, other locoregional therapies (e.g., TACE, HAIC), or prior immunotherapy or targeted therapy.
- Note: Patients who developed recurrence after prior surgery may be enrolled; if prior postoperative adjuvant therapy was given, enrollment is allowed only if ≥6 months have elapsed since completion of adjuvant therapy.
- Known cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular-cholangiocarcinoma, or fibrolamellar carcinoma; or any other active malignancy besides HCC within the past 5 years or concurrently (except cured basal cell carcinoma of the skin and cervical carcinoma in situ).
- Hypertension inadequately controlled with antihypertensive therapy (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg); or history of hypertensive crisis or hypertensive encephalopathy.
- Known hypersensitivity to macromolecular protein preparations, or known allergy to tislelizumab, lenvatinib, or any of their excipients.
- Any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis/colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo, or asthma that completely resolved in childhood and requires no intervention in adulthood, may be eligible. Patients with asthma requiring medical intervention with bronchodilators are not eligible.
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- Use of immunosuppressive agents or systemic, or absorbable topical, corticosteroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
- Symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage.
- Uncontrolled clinically significant cardiac symptoms or disease, including any of the following:
- New York Heart Association (NYHA) class > II heart failure
- Unstable angina
- Myocardial infarction within 1 year
- Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention
- Within the past 3 months, presence of gastrointestinal conditions such as esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or active bleeding from an unresected tumor; or any other condition judged by the investigator to confer a risk of gastrointestinal bleeding or perforation.
- History of or current severe bleeding (within 3 months, bleeding volume >30 mL), hemoptysis (within 4 weeks, >5 mL fresh blood), or thromboembolic events within 12 months (including stroke and/or transient ischemic attack).
- Active infection, or unexplained fever >38.5°C during screening or prior to first dose (fever judged by the investigator to be tumor-related is allowed).
- Objective evidence of prior or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function.
- Congenital or acquired immunodeficiency, such as HIV infection.
- Receipt of a live vaccine within 4 weeks prior to study drug administration, or anticipated need for live vaccination during the study.
- Known history of psychotropic drug abuse, alcoholism, or illicit drug use.
- Anticipated inability or unwillingness to comply with required study procedures, assessments, and follow-up (including completion of standard-of-care evaluations not covered by the study), as judged by the investigator.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for the study, including factors that may lead to premature study discontinuation (e.g., other serious diseases [including psychiatric disorders] requiring concomitant treatment, severe laboratory abnormalities, or family/social factors that may compromise subject safety or the collection of data and specimens).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianqiang Song, +8618622221077, tjchi@hotmail.com
About this study
Official title: Tislelizumab Plus Lenvatinib as Neoadjuvant Therapy for Patients With Resectable HCC at High Risk of Recurrence: a Prospective, Multicenter, Randomized Controlled Phase III Study
This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.
Read the detailed description
Hepatectomy remains the primary curative treatment for HCC. However, the high rate of postoperative recurrence significantly limits long-term survival. For patients with resectable HCC at high risk of recurrence, strategies to reduce postoperative recurrence and prolong overall survival are needed. Previous studies have reported that combination regimens of immune checkpoint inhibitors plus antiangiogenic agents show promising efficacy and safety in the perioperative setting for HCC. This prospective, multicenter, randomized controlled phase 3 study aims to evaluate the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Tislelizumab, Lenvatinib
- 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 group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | The Surgery-alone Group: the patients will receive surgery alone after enrollment and randomization. |
| Arm B | Experimental | The 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-year event-free survival rate
Measured: 1 year after randomization
Secondary outcomes (10)
Objective response rate
Measured: 6 weeks after randomization
Disease control rate
Measured: 6 weeks after randomization
Major pathologic response rate
Measured: 10 weeks after randomization
1-year recurrence-free survival rate
Measured: 1 year after randomization
2-year recurrence-free survival rate
Measured: 2 year after randomization
Recurrence-free survival
Measured: 36 months after randomization
Event-free survival
Measured: 36 months after randomization
Overall survival
Measured: 48 months after randomization
Incidence of surgery delay
The proportion of patients who were scheduled to undergo surgery who did not have surgery performed in a predetermined window
Measured: 10 weeks after randomization
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.
- First posted16 Mar 2026
- Study start9 Jun 2026
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475026
- Sponsor's protocol ID
- 2512012685
- Acronym
- Neo-LENTIS
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 5 Aug 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Plus Lenvatinib as Neoadjuvant Therapy for Patients With Resectable HCC at High Risk of Recurrence: a Prospective, Multicenter, Randomized Controlled Phase III Study
- ClinicalTrials.gov ID
- NCT07475026
- Acronym / sponsor ID
- Neo-LENTIS / 2512012685
- Conditions
- HCC - Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Mar 2026 (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.
This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.
Detailed description
Hepatectomy remains the primary curative treatment for HCC. However, the high rate of postoperative recurrence significantly limits long-term survival. For patients with resectable HCC at high risk of recurrence, strategies to reduce postoperative recurrence and prolong overall survival are needed. Previous studies have reported that combination regimens of immune checkpoint inhibitors plus antiangiogenic agents show promising efficacy and safety in the perioperative setting for HCC. This prospective, multicenter, randomized controlled phase 3 study aims to evaluate the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –The Surgery-alone Group: the patients will receive surgery alone after enrollment and randomization. |
| Arm B | Experimental | Drug: Tislelizumab, Drug: LenvatinibThe Neoadjuvant Treatment Group: the patients will receive 2 cycles of neoadjuvant tislelizumab plus lenvatinib after enrollment and randomization and receive surgery in sequence. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Voluntarily participates in this study and provides written informed consent.
- Aged 18 to 75 years, inclusive; male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Child-Pugh class A liver function.
- China Liver Cancer (CNLC) stage Ib to IIa.
Key exclusion criteria (22 listed)
- Prior antitumor therapy for the current HCC, including radiotherapy, chemotherapy, concurrent chemoradiotherapy, other locoregional therapies (e.g., TACE, HAIC), or prior immunotherapy or targeted therapy.
- Note: Patients who developed recurrence after prior surgery may be enrolled; if prior postoperative adjuvant therapy was given, enrollment is allowed only if ≥6 months have elapsed since completion of adjuvant therapy.
- Known cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular-cholangiocarcinoma, or fibrolamellar carcinoma; or any other active malignancy besides HCC within the past 5 years or concurrently (except cured basal cell carcinoma of the skin and cervical carcinoma in situ).
- Hypertension inadequately controlled with antihypertensive therapy (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg); or history of hypertensive crisis or hypertensive encephalopathy.
- Known hypersensitivity to macromolecular protein preparations, or known allergy to tislelizumab, lenvatinib, or any of their excipients.
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 |
|---|---|---|
| TislelizumabTislelizumab, 200mg, IV, q3w. Treatment will be given in 3-week cycles for a total of 2 cycles. | Drug | Arm B |
| LenvatinibLenvatinib, 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. | Drug | Arm B |
Primary outcome
1-year event-free survival rate
Time frame: 1 year after randomization
10 secondary outcomes
Objective response rate
Time frame: 6 weeks after randomization
Disease control rate
Time frame: 6 weeks after randomization
Major pathologic response rate
Time frame: 10 weeks after randomization
1-year recurrence-free survival rate
Time frame: 1 year after randomization
2-year recurrence-free survival rate
Time frame: 2 year after randomization
Recurrence-free survival
Time frame: 36 months after randomization
Event-free survival
Time frame: 36 months after randomization
Overall survival
Time frame: 48 months after randomization
Incidence of surgery delay
Time frame: 10 weeks after randomization
Incidence of treatment-related adverse events(graded per CTCAE v5.0)
Time frame: 10 weeks after randomization
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 5 Aug 2026.
- Individual participant dataSharing planned: 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab and Lenvatinib in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 26 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Tianqiang Song (+8618622221077, tjchi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year event-free survival rate (time frame: 1 year after randomization). 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 5 Aug 2026.