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Hepatocellular CarcinomaPhase 2NCT04954794

TACE Combined with Sintilimab Plus Bevacizumab Biosimilar in Patients with Advanced Hepatocellular Carcinoma (TASK-02)

A Phase 2 study testing Sintilimab and TACE in people with Hepatocellular Carcinoma, run by Fudan University 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

The objective of this study is to evaluate the efficacy and safety of TACE combined with Sintilimab plus bevacizumab biosimilar in patients with advanced hepatocellular carcinoma as first-line therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sintilimab and TACE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
14 Jul 2021to 29 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent obtained.
  • Age ≥ 18 years at time of study entry.
  • Barcelona Clinic Liver Cancer stage C.
  • Histologically confirmed diagnosis of HCC.
  • At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI，apart from one liver lesion to serve for TACE.
  • Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
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  • Subjects with chronic HBV infection must have HBV DNA viral load < 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
  • Life expectancy of at least 12 weeks.
  • Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula)
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

Who cannot join

  • Patients on a liver transplantation list or with advanced liver disease.
  • Total thrombosis or total invasion of the main branch of the portal vein.
  • History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
  • Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
  • Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy
  • Prior treatment with TACE
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  • RFA and resection administered less then 4 weeks prior to study treatment start.
  • Radiotherapy administered less then 4 weeks prior to study treatment start.
  • Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
  • Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
  • Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.
  • Previous treatment in the present study (does not include screening failure).
  • Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:
  • history of interstitial lung disease
  • Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
  • known acute or chronic pancreatitis
  • active tuberculosis
  • any other active infection (viral, fungal or bacterial) requiring systemic therapy
  • history of allogeneic tissue/solid organ transplant
  • diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy treatment.
  • Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.
  • Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment.
  • History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.
  • Medication that is known to interfere with any of the agents applied in the trial.
  • Any other efficacious cancer treatment except protocol specified treatment at study start.
  • Patient has received any other investigational product within 28 days of study entry.
  • Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined with Sintilimab Plus Bevacizumab Biosimilar in Patients with Advanced Hepatocellular Carcinoma (TASK-02)

The objective of this study is to evaluate the efficacy and safety of TACE combined with Sintilimab plus bevacizumab biosimilar in patients with advanced hepatocellular carcinoma as first-line therapy.

Read the detailed description

Transarterial chemoembolization (TACE) is commonly used for the treatment of advanced hepatocellular carcinoma. Early randomized trials suggested that TACE can be accepted as the standard treatment for advanced-stage disease. However, the outcome of patients treated with TACE in real-life cohorts is still very poor.

Recent studies have also supported a safe combination of immune checkpoint inhibition with TACE. And the combination of sintilimab plus bevacizumab biosimilar showed significantly improved survival in advanced HCC. Therefore, the objective of this study is to evaluate the efficacy and safety of TACE combined with anti-PD-1 antibody in patients in advanced hepatocellular carcinoma.

Being tested
Sintilimab, TACE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • SintilimabDrug

    Sintilimab will be administered at 200 mg i.v. every 3 weeks plus a bevacizumab biosimilar at 15 mg/kg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

  • TACECombination product

    TACE is performed by using drug-eluting beads or using microspheres combined with Lipiodol-pirarubicin emulsion per Investigator's decision. TACE treatment starts at day 0. Sintilimab plus a bevacizumab biosimilar will be initiated on day 14 after TACE.

Study groups in NCT04954794
Study groupRoleWhat they receive
TACE in combination with Sintilimab plus a bevacizumab biosimilarExperimentalNot described
Receives: Drug: Sintilimab; Combination Product: TACE

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR according to RECIST 1.1 for HCC

    Measured: max 24 months

Secondary outcomes (5)

  1. Duration of Response

    Measured: max 24 months

  2. Progression-Free Survival

    Measured: max 24 months

  3. Overall survival

    Measured: max 42 months

  4. Disease control rate

    Measured: max 24 months

  5. Adverse Events

    Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE).

    Measured: max 42 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 Jul 2021
  2. Study start14 Jul 2021
  3. Primary completion29 Apr 2024
  4. Study completion29 Apr 2024

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04954794
Sponsor's protocol ID
MIT-011
Status last verified
Oct 2024
First submitted
1 Jul 2021
Last updated
31 Oct 2024
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 Sintilimab and TACE in people with Hepatocellular Carcinoma, run by Fudan 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 11 inclusion and 30 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 31 Oct 2024. 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?

Objective Response Rate (ORR) (time frame: max 24 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 NCT04954794.

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 31 Oct 2024.

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