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Resectable Hepatocellular CarcinomaPhase 2NCT04834986

Tislelizumab Combined With Lenvatinib for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, one-arm, phase II clinical study of Tislelizumab combined with Lenvatinib for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence. 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 combined with Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
30 Apr 2021to 30 Apr 2024
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 volunteered to participate in this study and signed informed consent;
  • Age 18-75, male or female;
  • ECOG PS score 0-1;
  • Child-pugh liver function grading: Grade A
  • The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to the indications for resectable operation in the Guidelines for diagnosis and Treatment of HCC (2019) edition;
  • According to the preoperative evaluation of the researcher, the patient had a high risk of recurrence and met at least one of the risk factors:
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  • Ⅰb: a single tumor diameter > 6.5 cm (except Mr Tian Bangxiong inflating),2-3 tumors with the maximum diameter ≤3cm;
  • a : tumor 2-3,biggest > 3 cm in diameter
  • b: tumor 4 or higher
  • a: vascular invasion to the naked eyes;
  • According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
  • Expected survival ≥ 6 months;
  • 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 ≤ 2.5 times the upper limit of normal value (ULN); Urine protein <2+;If urinary protein ≥2+,24-hour quantitative urine protein must be ≤1g;
  • Normal coagulation function, no active bleeding and thrombotic disease A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN; C. Prothrombin time PT≤1.5ULN;
  • Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication; Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period;
  • Subjects have good compliance and cooperate with the follow-up.

Who cannot join

  • Have received radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapies before;
  • Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma; Active malignancies other than HCC within 5 years or concurrently;
  • Having hypertension that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous history of hypertension crisis or hypertensive encephalopathy;
  • Subject has previous or concurrent malignancies (except cured basal cell carcinoma of skin and carcinoma in situ of the cervix);
  • Previous treatment with Tislelizumab or other PD-1/PD-L1 treatment could not be enrolled; Subjects are known to have prior allergies to macromolecular protein reparations or to any Tislelizumab or Lenvatinib excipients;
  • Subject has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma have been completely relieved and may be included as adults without any intervention; Asthma requiring medical intervention with bronchodilators will not be included);
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  • Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy within 2 weeks prior to enrollment;
  • Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage;
  • Clinical symptoms or diseases of the heart that are not well controlled, such as:
  • NYHA2 or above heart failure
  • Unstable angina pectoris
  • Myocardial infarction occurred within 1 year
  • Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
  • The patient currently (within 3 months) has gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding in unresected tumors, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation;
  • Past or present severe bleeding (>30 ml bleeding within 3 months), hemoptysis (>5 ml fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or tia) within 12 months;
  • Subject has active infection or unexplained fever of >38.5 degrees during screening and before first administration (subject's fever due to tumor can be enrolled according to the investigator's judgment);
  • Patients with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, severe impairment of lung function, etc.;
  • Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000/ml; Hepatitis C reference: HCV RNA≥103/ml);Chronic hepatitis B virus carriers, HBV DNA < 1000 IU/ml, must receive antiviral treatment at the same time during the test can be enrolled;
  • Live vaccine is administered less than 4 weeks before or possibly during the study period;
  • The subject has a known history of psychotropic substance abuse, alcohol abuse or drug abuse;
  • The subject cannot or does not agree to bear the cost of the self-funded portion of the examination and treatment, except for the clinical study drug, combined chemotherapy and SAE related to the clinical study drug combined chemotherapy;
  • Researchers think that should be left out in this study, the researchers determine, for example, the subjects have other factors that may result in this study were forced to midway termination, such as, other serious disease (including mental illness) need to merge treatment, there are serious abnormal laboratory examination, accompanied by factors such as family or society, will affect the safety of the subjects, or information and the collection of the sample.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Insititute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: A Prospective, One-arm, Phase II Clinical Study of Tislelizumab Combined With Lenvatinib for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma With a High Risk of Recurrence.

This is a prospective, one-arm, phase II clinical study of Tislelizumab combined with Lenvatinib for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.

Being tested
Tislelizumab combined with Lenvatinib

What participants receive

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

  • Tislelizumab combined with LenvatinibDrug

    Pre-operation: Tislelizumab, 200mg, iv,d1,q3w, 2-4 cycles; Lenvatinib,8mg/kg,po,qd,d1-d84.

    Operation Postoperation: 4-8 weeks after surgery, Tislelizumab, 200mg, iv,d1,q3w; Lenvatinib,8mg/kg,po,qd, up to one year.

Study groups in NCT04834986
Study groupRoleWhat they receive
Tislelizumab combined with LenvatinibExperimentalNot described
Receives: Drug: Tislelizumab combined with Lenvatinib

What is being measured

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

  1. Safety as measured by the number of grade 3 and grade 4 adverse events that occurred when subjects participated in the study, as defined by CTCAE v5.0.

    Measured: 36 months

  2. Feasibility as measured by rate of enrollment

    It's defined as a delay of surgery for any reason no more than 49 days compared to the specified planned surgery time (i.e., delay of surgery ≤42 days and scheduled surgery for 7 days).

    Measured: 3 months

Secondary outcomes (6)

  1. objective response rate(ORR)

    Measured: 2 months

  2. 1-year disease-free survival rate (1-year DFS%)

    Measured: 12 months

  3. pathological complete response(pCR)

    Measured: 3 months

  4. 2-year disease-free survival rate (2-year DFS%)

    Measured: 24 months

  5. disease-free survival(DFS)

    Measured: 24 months

  6. adverse reactions

    AEs and SAE

    Measured: 36 months

Timeline

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

  1. First posted8 Apr 2021
  2. Study start30 Apr 2021 (estimated)
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2024 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04834986
Sponsor's protocol ID
GDS20201110564038
Status last verified
Apr 2021
First submitted
6 Apr 2021
Last updated
8 Apr 2021
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 combined with 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 20 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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?

Results are not available in the source record.

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?

Safety as measured by the number of grade 3 and grade 4 adverse events that occurred when subjects participated in the study, as defined by CTCAE v5.0. (time frame: 36 months). The study lists 2 primary outcomes in all. 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 NCT04834986.

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 8 Apr 2021.

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