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Hepatocellular CarcinomaPhase 2NCT05897138

A Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses

A Phase 2 study testing Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle in people with Hepatocellular Carcinoma, run by Fujian Cancer 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

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Aug 2023to 1 Jun 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent before screening;
  • Age ≤ 18 years old ≤75 years old for both men and women;
  • ECOG score 0-1;
  • A clinical or pathological diagnosis of hepatocellular carcinoma should meet one of the following criteria: ① A histological or cytological diagnosis of hepatocellular carcinoma, except for fibrolamellar, sarcomatoid or mixed cholangiocarcinoma; ② According to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition), the patient was clinically diagnosed with HCC;
  • Hepatitis B virus surface antigen (HBsAg) positive and hepatitis B virus (HBV) DNA<2000IU/ml or 104 copies /ml; Or hepatitis B virus core antibody (HBcAb) positive, HBsAg negative, and highly sensitive HBV DNA<2000IU/ml or 104 copies /ml;
  • have not previously received any systemic therapy for HCC (mainly including systemic chemotherapy, antivascular therapy, molecular targeted therapy, immunotherapy targeting any other antibodies or drugs that act on T-cell co-stimulation or immune checkpoint pathways, Including but not limited to anti-PD-1, anti-PD-L1 /L2, anti-CD137 or anti-ctLA-4 antibodies), and disease progression 6 months after the end of postoperative adjuvant chemotherapy were allowed to be enrolled;
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  • Chinese clinical stage of liver cancer (CNLC) Ⅲb or CNLC Ⅱb-Ⅲa which is not suitable for surgery and/or local treatment;
  • Child-Pugh rating for liver function: Grade A and good Grade B (≤7 points), and no history of hepatic encephalopathy;
  • There is at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), and there is definite disease progression for lesions previously treated locally
  • Can be selected as a target lesion;
  • 10) Expected survival of more than 3 months;
  • 11) Major organ function is normal (no blood component, cell growth factor or albumin infusion therapy has been given within 14 days prior to laboratory examination), if the following criteria are met:
  • Blood routine: neutrophil ≥1.5×l09/L, platelet ≥75×109/L, hemoglobin ≥90g/L;
  • Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST≤5×ULN; Serum albumin ≥28g/L; Total bilirubin (TBIL) ≤2×ULN; Alkaline phosphatase (ALP) ≤5×ULN;
  • Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥50mL/min;
  • Urine protein <2+ by routine detection; If urine protein ≥2+ at baseline, 24-hour urine protein quantity must be ≤1.0g;
  • Coagulation function: activated partial thromboplastin time (APTT), International Normalized Ratio (INR), prothrombin time (PT) ≤1.5×ULN;
  • Echocardiography: left ventricular ejection fraction (LVEF) ≥50%;

Who cannot join

  • Liver surgery and/or local treatment for HCC, except palliative radiotherapy for bone metastases to relieve pain, had been performed within 4 weeks prior to initial study drug therapy;
  • Subjects (except hair loss and fatigue) who have not recovered from any toxicity and/or complications of local therapy (including interventional therapy, radio frequency therapy, etc.), previous chemotherapy, surgery, radiotherapy, that is, have not fallen to ≤ Grade 1 (NCI CTCAE version 5.0);
  • Have received anti-tumor drug therapy in the past (including but not limited to traditional Chinese medicine preparations with anti-tumor indications);
  • With moderate or severe ascites or ascites requiring drainage, or with pleural or pericardial effusion requiring drainage and/or symptoms of shortness of breath;
  • with known active central nervous system metastases (CNS) and/or cancerous meningitis;
  • With other malignancies (other than cured cervical carcinoma in situ, non-melanoma skin cancer or other tumors/cancers that have been treated radically and have shown no signs of disease for at least 5 years);
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  • Combined history of bleeding tendency, high risk of bleeding, or cocoagulation dysfunction, including an arteriovenous thromboembolism event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolism in the 6 months prior to screening;
  • 8) The portal vein cancer thrombus involved the main trunk, or both the main trunk and the superior mesenteric vein, or the inferior vena cava cancer thrombus or heart involvement;
  • 9) Unhealed wounds, active digestive tract ulcers or bleeding, fractures (excluding healed old fractures);
  • 10) Esophageal or gastric varicose bleeding occurred within 6 months prior to treatment, or severe varicose veins were known to exist on endoscopic examination.
  • 11) A history of gastrointestinal perforation and/or fistula, abdominal abscess, 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 long-term chronic diarrhea within 6 months prior to treatment;
  • 12) Patients who had undergone major surgery within 4 weeks prior to enrollment or expected to undergo major surgery during the study period (except for diagnostic biopsy);
  • 13) Having a known or suspected autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), having a history of human immunodeficiency virus infection (HIV positive), or having other acquired or congenital immunodeficiency diseases.
  • 14) Patients with a history of active tuberculosis or active or uncontrolled infection requiring systematic treatment (except simple urinary tract infection or upper respiratory tract infection) or syphilis infection requiring treatment;
  • 15) Subjects with a combined history of interstitial lung disease, non-infectious pneumonia, or high suspicion of having interstitial lung disease; Subjects with a history of drug-induced or radiological noninfectious pneumonia without symptoms were admitted;
  • 16) A history of severe medical disease, such as grade III or higher cardiac dysfunction (New York Heart Association [NYHA]), ischemic heart disease (such as myocardial infarction or angina), or myocardial infarction within the 3 months prior to enrollment, Subjects with poorly controlled diabetes (fasting blood glucose ≥10mmol/L) after medication or hypertension (systolic blood pressure >140mmHg and/or diastolic blood pressure >90mmHg) after medication and with prior hypertensive crisis or hypertensive encephalopathy;
  • 17) Receive live vaccines (except seasonal influenza vaccines that do not contain live viruses) within 4 weeks before the first study drug treatment or during the planned study period;
  • 18) Allergic to any component of tirelizumab or Lenvatinib, or known allergic to any other monoclonal antibody;
  • 19) Pregnant or lactating women, or subjects who plan to become pregnant during the treatment period and within 6 months after the end of treatment; Unwillingness to use effective contraception (including male subjects with the ability to impregnate women and female subjects and their male partners) during the study and for at least 6 months after the last study medication;
  • 20) The subject is known to have a history of drug addiction or mental illness;

About this study

Official title: A Phase 2, Multi-Center, Single Arm Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses.

Read the detailed description

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses.

Being tested
Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycleDrug

    Drug: Lenvatinib Capsules administered orally once daily

    Drug: Tislelizumab 200 mg intravenous (IV) infusion administered on Day 1 of each cycle

Study groups in NCT05897138
Study groupRoleWhat they receive
Lenvatinib plus TislelizumabExperimentalNot described
Receives: Drug: Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle

What is being measured

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

  1. Objective response rate (ORR)

    the proportion of participants who got a complete response (CR) and partial response (PR) according to RECIST v1.1.

    Measured: 12 months

Secondary outcomes (5)

  1. Incidence of Treatment-Emergent Adverse Events

    Incidence of Treatment-Emergent Adverse Events were evaluated in accordance with the NCI CTC AE Version 5.0

    Measured: from first dose to within 30 days after the last dose

  2. Duration of response (DOR)

    time from CR or PR (RECIST v1.1) achievement with investigational therapy, until documented progression, relapse, or death due to disease progression

    Measured: time from CR or PR (RECIST v1.1) achievement with investigational therapy, until documented progression, relapse, or death due to disease progression

  3. Disease Control Rate (DCR)

    the percentage of patients who have achieved CR, PR, and SD.

    Measured: 12 months

  4. Progression-Free Survival (PFS)

    the period from treatment initiation until the date of disease progression, death, or study cutoff, whichever occurred first.

    Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  5. Overall survival(OS)

    OS was defined as the time from the date of treatment to the date of death due to any cause. For subjects who were alive or lost to follow-up by the data analysis cut-off date, survival was censored at the subject's last known survival time.

    Measured: From date of treatment until the date of death from any cause, whichever came first, assessed up to 100 months

Timeline

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

  1. First posted9 Jun 2023
  2. Study start1 Aug 2023 (estimated)
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 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 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
NCT05897138
Sponsor's protocol ID
Glitter-01
Status last verified
Jun 2023
First submitted
13 May 2023
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycle in people with Hepatocellular Carcinoma, run by Fujian Cancer 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 18 inclusion and 20 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 13 Jun 2023. 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?

Objective response rate (ORR) (time frame: 12 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 NCT05897138.

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 13 Jun 2023.

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