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Resectable Hepatocellular CarcinomaPhase 2NCT05807776

Tislelizumab Monotherapy or Combined With Lenvatinib as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma.

A Phase 2 study testing Tislelizumab and Tislelizumab, Lenvatinib in people with Resectable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase II prospective study to evaluate the safety and efficacy of Tislelizumab monotherapy or combined with lenvatinib as neoadjuvant therapy for resectable hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Resectable Hepatocellular Carcinoma
What is being tested?
Tislelizumab and Tislelizumab, Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
24 Apr 2023to 31 Jul 2025
Phase
Phase 2
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

Who may be able to join

  • Patients must have a known diagnosis of HCC as defined in the protocol
  • Patients must be evaluated by the Department of Hepatobiliary Oncology, Tianjin Medical University Cancer Hospital to determine whether they can complete surgical treatment. Patients can be resectable in both oncology and surgery.
  • At least ≥1 measurable lesion (RECIST 1.1)
  • Age 18-75, male or female
  • ECOG PS 0-1
  • Child-pugh A
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  • The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days)
  • Blood routine:
  • Neutrophils ≥1.5×109//L Platelet count ≥100×109/L Hemoglobin ≥90g/L
  • Liver and kidney function:
  • Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula) Total bilirubin (TBIL)≤ 1.5 times the upper limit of normal value (ULN) AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)
  • Normal coagulation function, International standardized ratio INR≤1.5×ULN or Prothrombin time PT≤1.5ULN
  • Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range may be enrolled if total T3 (or FT3) and FT4 are within the normal range.
  • Myocardial enzyme profiles were within the normal range (simple laboratory abnormalities that were not clinically significant were also allowed to be included)
  • Patients who have progressed to PD or increased SD after 2 cycles of tislelizumab monotherapy must be willing to continue 2 cycles of tislelizumab and Lenvatinib combination therapy and be evaluated.

Who cannot join

  • Have received any systemic anticancer therapy or radiotherapy for their current tumor or other primary tumor in the 6 months prior to study entry.
  • Tumor load or tumor growth rate was considered by the investigator to be insufficient to delay surgery.
  • Had major surgery within 14 days prior to neoadjuvant therapy.
  • Uncontrolled co-morbidities defined in the protocol and identified by the investigator.
  • Receiving systemic steroid therapy or any other immunosuppressive therapy within 7 days prior to administration of the first dose of study therapy.
  • Have had an active autoimmune disease requiring systemic treatment within the past 1 year.
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  • Have other malignancies that are known, developing and/or require aggressive treatment.
  • Informed consent to encephalitis, meningitis, or uncontrolled seizures in the previous year.
  • A history of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, systemic pneumonia) or active non-infectious pneumonia requires immunosuppressive doses of glucocorticoids to assist in treatment.
  • Bleeding from esophageal or fundus varices caused by portal hypertension in the past 6 months; Severe (G3) varicose veins were known on endoscopy within 3 months prior to initial administration; Patients with evidence of portal hypertension (including imaging findings of a large spleen diameter of more than 10cm and platelets of less than 100) were at high risk of bleeding as assessed by the investigators.
  • History of arteriovenous thromboembolism events within the past 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, except in patients with stable thrombus after conventional anticoagulant therapy.
  • Severe bleeding tendency or coagulopathy, or receiving thrombolytic therapy.
  • Prophylactic use of low-dose, low-molecular heparin (e.g., enoxaparin 40 mg/ day) is permitted, except for vitamin K antagonists (e.g., warfarin).
  • Long-term use of drugs that inhibit platelet function such as aspirin, dipyridamole or clopidogrel is required.
  • Uncontrolled hypertension, systolic blood pressure > 140mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
  • Symptomatic congestive heart failure (New York Cardiological Association Grade II-IV), symptomatic or poorly controlled arrhythmias, history of congenital long QT syndrome or adjusted QTc > 500ms at screening (calculated using the Fridericia method).
  • A previous history of gastrointestinal perforation and/or fistula within the past 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive enterectomy (partial resection of the colon or extensive resection of the small intestine with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: A Phase II Prospective Study to Evaluate the Safety and Efficacy of Tislelizumab Monotherapy or Combined With Lenvatinib as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma.

This is a phase II prospective study to evaluate the safety and efficacy of Tislelizumab monotherapy or combined with lenvatinib as neoadjuvant therapy for resectable hepatocellular carcinoma.

Being tested
Tislelizumab, Tislelizumab, Lenvatinib

What participants receive

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

  • TislelizumabDrug

    Tislelizumab 200mg, iv, d1, Q3W

  • Tislelizumab, LenvatinibDrug

    Tislelizumab combined with lenvatinib:

    Tislelizumab 200mg, iv, d1, Q3W Lenvatinib 8mg，po，qd.

Study groups in NCT05807776
Study groupRoleWhat they receive
tislelizumabExperimentalReceived tislelizumab for 2 cycles, 200mg, iv, d1,Q3W. Patients achieved PR or non-enlarged SD were enrolled in arm 1 and accepted surgery. After surgery, patients in arm 1 would receive tislelizumab as adjuvant therapy for 3-6 months.
Receives: Drug: Tislelizumab
tislelizumab+lenvatinibExperimentalReceived tislelizumab for 2 cycles, 200mg, iv, d1,Q3W. Patients achieved PD or enlarged SD were enrolled in arm 2 and continued to accept treatment with tislelizumab and lenvatinib for 2 cycles. After 2 cycles, patients would receive surgery according to their physical conditions. After surgery, patients in arm 2 would receive tislelizumab and lenvatinib as adjuvant therapy for 3-6 months.
Receives: Drug: Tislelizumab; Drug: Tislelizumab, Lenvatinib

What is being measured

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

  1. MPR rate

    tumor necrosis rate ≥ 50%

    Measured: 4 months

Secondary outcomes (6)

  1. 1-year and 2-years DFS%

    1-year and 2-years disease-free survival rate

    Measured: 36 months

  2. ORR

    objective response rate

    Measured: 3 months

  3. Surgery delay rate

    Surgery was performed more than 28 days after the last cycle of neoadjuvant therapy

    Measured: 3 months

  4. MiVI rate

    Incidence of microvascular invasion

    Measured: 3 months

  5. mOS

    Median Overall survival

    Measured: 5 years

  6. AE and SAE

    adverse reactions

    Measured: 1 year

Timeline

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

  1. First posted11 Apr 2023
  2. Study start24 Apr 2023
  3. Primary completion24 Jul 2024
  4. Study completion31 Jul 2025

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05807776
Sponsor's protocol ID
2211001174
Status last verified
Mar 2023
First submitted
29 Mar 2023
Last updated
1 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and Tislelizumab, Lenvatinib in people with Resectable 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 15 inclusion and 17 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 1 Apr 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 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?

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?

MPR rate (time frame: 4 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 NCT05807776.

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 1 Apr 2026.

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