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Hepatocellular CarcinomaPhase 2NCT05312216

Durvalumab Plus Lenvatinib as First-line Treatment for Unresectable Hepatocellular Carcinoma

A Phase 2 study testing Durvalumab plus Lenvatinib in people with Hepatocellular Carcinoma, run by Zhejiang University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 phase II, open-label study to evaluate the efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Durvalumab plus Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
Apr 2023to Jun 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects volunteer to participate in the study and sign the informed consent before enrollment.
  • 18-80 years of age.
  • ECOG score of 0-1.
  • Primary liver cancer with a pathological diagnosis of hepatocellular carcinoma.
  • Child-Pugh grade A (5-6 points).
  • BCLC C stage or BCLC B stage not suitable/refused for locoreginal treatments.
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  • Tumor volume ≤ 50% of the total liver volume.
  • Without prior systemic therapy and unwilling to receive standard systemic therapy or unsuitable for standard systemic therapy.
  • At least one measurable lesion as defined by RECIST v1.1 criteria.
  • Patients infected with hepatitis virus should receive antiviral therapy regularly.
  • No history of drug allergy.
  • Function of vital organs in accordance with the following requirements (no blood components, cell growth factors and other corrective therapeutic agents are allowed within 14 days prior to enrolment): Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelets ≥ 80 x 10^9/L; Haemoglobin ≥ 90 g/L; Serum albumin ≥ 35 g/L; Thyrotropin (TSH) ≤ 1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time, if FT3 and FT4 levels are normal, enrollment is allowed); Serum bilirubin ≤ 1.5 x ULN (within 7 days prior to first dose); ALT and AST ≤ 5 x ULN (within 7 days prior to first dose); International normalised ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 x ULN; Serum creatinine ≤ 1.5 x ULN.
  • Female patients who are non-surgically sterilised or of childbearing age are required to use contraception (e.g. IUD, pill or condom) during and for 3 months after the end of the treatment; female patients of childbearing age who are non-surgically sterilised must have a negative serum or urine HCG test within 72h prior to study entry; and must be non-lactating; male patients whose partners are women of childbearing age should be tested during the trial and for 3 months after the last dose. Male patients whose partners are women of childbearing age should use an effective method of contraception during the trial and for 3 months after the last dose.

Who cannot join

  • Patients with any active autoimmune disease or history of autoimmune disease (e.g. the following but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, autoimmune hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, vitiligo. Patients with complete remission of asthma in childhood who do not require any intervention in adulthood may be included, but those require bronchodilators cannot be included.
  • Patients who are on immunosuppressive drugs, or require systemic hormone therapy for immunosuppression purposes (doses >10 mg/day of prednisone or other isotonic hormones) and who continue to use them within 2 weeks prior to enrollment.
  • Receiving systemic therapy previously or other anti-cancer treatments (e.g. radiofrequency ablation, interventional therapy, radiotherapy, etc.)
  • Patients with a known history of central neural system metastases or hepatic encephalopathy.
  • Patients with clinically symptomatic ascites requiring puncture or drainage or those who have received ascites drainage within the previous 3 months.
  • Patients with hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
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  • Having clinical cardiac symptoms or disease not well controlled, such as (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc > 450 ms (men); QTc > 470 ms (women).
  • With abnormal coagulation (INR > 2.0, PT > 16s), bleeding tendency or on thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin or low molecular heparin is allowed.
  • Patients had clinically significant bleeding symptoms or a clear bleeding tendency within the 3 months prior to enrollment.
  • Having arterial/venous thrombotic events within the 6 months prior to enrollment.
  • With hereditary or acquired bleeding and thrombotic tendencies.
  • With urine protein ≥ ++ and confirmed by 24-hour urine protein amount > 1.0 g.
  • Patients with active infection, unexplained fever ≥ 38.5°C within 7 days prior to the first dose, or baseline white blood cell count > 15 x 10^9/L.
  • Patient with a congenital or acquired immune deficiency (e.g. HIV infection).
  • Patient with other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the previous 3 years or concurrently.
  • Patients who have other factors that could affect the outcome of the study or force the termination of the study, such as alcoholism, substance abuse, other serious illnesses (including psychiatric illness) requiring comorbid treatment.

Trial locations and contacts

1 site in 1 country.

Tingbo Liang, PhD contact

+86 19941463683

liangtingbo@zju.edu.cn

China1 site

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Study on the Efficiency and Safety of Durvalumab Plus Lenvatinib as First-line Treatment for Unresectable Hepatocellular Carcinoma: an Open, Single Arm, Phase II Clinical Trial

This is a phase II, open-label study to evaluate the efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma.

Read the detailed description

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Durvalumab plus Lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma. The primary endpoint is the objective response rate (ORR) according to RECIST v1.1. Safety evaluation will be taken according to CTCAE v5.0. Disease control rate (DCR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS) are secondary endpoints. Multi-omics analysis will be performed to identify potential biomarkers for treatment response.

Being tested
Durvalumab plus Lenvatinib
Keywords
hepatocellular carcinoma, Durvalumab, 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.

  • Durvalumab plus LenvatinibDrug

    Durvalumab: 1500mg, iv.drip, Q4w Lenvatinib: 8mg, QD (body weight < 60kg) or 12mg, QD (body weight ≥ 60kg)

    Number of cycle: until subjects withdrawing the informed consent OR progressive disease OR developing unacceptable toxicity events

Study groups in NCT05312216
Study groupRoleWhat they receive
Durvalumab plus LenvatinibExperimentalDurvalumab is a human IgG1 κ monoclonal antibody that inhibits binding of PD-L1 to its receptors PD-1 and CD80. Lenvatinib is a multi- kinase inhibitor of VEGF receptors 1 to 3, FGF receptors 1 to 4, PDGFRa, RET, and KIT.
Receives: Drug: Durvalumab plus Lenvatinib

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 patients who had tumor response evaluated as CR or PR according to RECIST v1.1 during study.

    Measured: up o one year

Secondary outcomes (5)

  1. Disease control rate (DCR)

    The proportion of patients who had tumor response evaluated as CR or PR or SD according to RECIST v1.1 during study.

    Measured: up to one year

  2. Duration of response (DOR)

    The duration from the first assessment of CR or PR to the first assessment of PD or death of any cause.

    Measured: up to one year

  3. Progression-free survival (PFS)

    The duration from the date of initial treatment to the date of disease progression (defined by RECIST v1.1) or death due to any cause.

    Measured: up to one year

  4. Overall survival (OS)

    The duration from the date of initial treatment to the date of death due to any cause.

    Measured: up to two years

  5. Adverse events (AEs)

    Any adverse events (including type, frequency and severity ) related with treatment drugs according to CTCAE v5.0.

    Measured: up to two years

Timeline

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

  1. First posted5 Apr 2022
  2. Study startApr 2023 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionJun 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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312216
Sponsor's protocol ID
HCCLEPL1
Status last verified
Jan 2023
First submitted
27 Mar 2022
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab plus Lenvatinib in people with Hepatocellular Carcinoma, run by Zhejiang University 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 13 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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?

Contact Tingbo Liang, PhD (+86 19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: up o one year). 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 NCT05312216.

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 26 Jan 2023.

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