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Hepatocellular CarcinomaPhase 2NCT04174781

Anti-PD-1 Antibody Plus DEB-TACE for BCLC Stage A/B HCC

A Phase 2 study testing Sintilimab and DEB-TACE 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection in combination with transarterial chemoembolization with drug-eluting beads(TACE-DEB) in patients with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria. 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?
Sintilimab and DEB-TACE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteChina
Study dates
20 Nov 2019to 30 Dec 2022
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

  • Age between 18 years and 75 years;
  • ECOG PS 0/1;
  • Patients with histologically- or clinically-confirmed HCC (based on the American Association for the Study of Liver Diseases criteria) that was either BCLC stage A and exceeded the Milan criteria, or BCLC stage B
  • Have not received any anti-tumor systemic treatment in the past
  • No contraindications for the treatment of DEB-TACE and PD-1 inhibitors;
  • Liver function: Child-Pugh score Class A
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  • The expected survival of the patient is more than 3 months
  • The following conditions must be met:
  • Platelets ≥ 75 × 10^9/L White blood cell count (WBC) ≥ 3.0 × 10^9/L Hemoglobin ≥ 90 g/L Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 × ULN Blood creatinine ≤ 1.5 × ULN PT prolonged ≤ 3 s
  • Adequate bone marrow, cardiac, and renal function
  • Patients must agree to accept postoperative follow-up required by the design of this study;
  • Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study.

Who cannot join

  • History of other malignancies；
  • In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (> CTCAE Version 5.0 adverse events of grade 2)；
  • With uncontrolled hepatitis B (HBV-DNA>2000 IU/ml and elevated ALT).
  • Spontaneous rupture and bleeding of HCC
  • Hepatic tumor burden >50% total liver volume
  • Complete occlusion of the portal vein
Show all 12Show fewer
  • Evidence of a bleeding diathesis or coagulopathy, active infections, and autoimmune disease
  • Recurrent disease after surgery within the last 5 years
  • History of organ transplantation or plan to have liver transplantation;
  • Pregnant women, nursing mothers.
  • Patients have other factors that may interfere with patient enrollment and assessment results.
  • Refuse follow-up as required by this study protocol and refuse to sign informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: Preoperative Anti-PD-1 Antibody Plus Drug-eluting Bead TACE for BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria: A Phase II Trial

This study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection in combination with transarterial chemoembolization with drug-eluting beads(TACE-DEB) in patients with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria.

Read the detailed description

Patients with hepatocellular carcinoma (HCC) of BCLC stage A/B exceeding the Milan criteria have a low resection rate and high postoperative recurrence rate, therefore, optimizing therapy for these patients is an important unmet need. This study aimed to investigate the efficacy and safety of preoperative DEB-TACE plus sintilimab for the treatment of patients with BCLC stage A/B HCC exceeding the Milan criteria.

Being tested
Sintilimab, DEB-TACE
Keywords
Hepatocellular carcinoma, Transarterial chemoembolization, Immunotherapy
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

    Also called Immunotherapy, Anti-PD-1 therapy

    Sintilimab: 200mg iv Q3W D1

  • DEB-TACEDrug

    Also called Drug-eluting Bead Transarterial Chemoembolization

    DEB-TACE(epirubicin 60mg) D1; Additional DEB-TACE procedures were carried out every 4-6 weeks based on tumor response. A treatment cycle was defined as one DEB-TACE procedure plus two doses of sintilimab. The combination of DEB-TACE and sintilimab was continued for a maximum of 3 cycles until surgical resection, radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first.

Study groups in NCT04174781
Study groupRoleWhat they receive
DEB-TACE+SintilimabExperimentalParticipants with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria
Receives: Drug: Sintilimab; Drug: DEB-TACE

What is being measured

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

  1. Progression Free Survival (PFS) per mRECIST

    The duration from treatment initiation to PD in patients who cannot undergo surgery, or to the date of postoperative relapse in patients who receive surgery, or death for any reason, whichever occurs first (according to mRECIST).

    Measured: 36 months

Secondary outcomes (6)

  1. 12 mo PFS rate

    The percentage of patients who have not progressed or relapsed or death at the 12 mo time point since the first time of treatment.

    Measured: 36 months

  2. Overall survival (OS)

    The duration from treatment initiation to death from any cause.

    Measured: 36 months

  3. Pathological Response

    Including Major Pathological response rate（MPR）and pathological complete response (pCR). MPR is defined as the presence of 10% or fewer viable tumour cells in the primary tumours. pCR is defined as no viable tumour cells in the specimen.

    Measured: 6 months

  4. Objective Response Rate (ORR) per mRECIST

    The proportion of complete response or partial response as optimal response among all treated patients according to mRECIST.

    Measured: 36 months

  5. Disease Control Rate (DCR) per mRECIST

    The proportion of complete response, partial response or stable disease as optimal response among all treated patients according to mRECIST.

    Measured: 36 months

  6. Adverse events (AEs)

    The incidence, relationship with study drugs, and severity level of all adverse events (AEs) according to CTCAE 5.0, treatment-emergent adverse events (TEAEs), treatment related adverse events (TRAEs), and serious adverse events (SAEs) and the changes in vital signs, physical examination results, and laboratory test results before, during, and after the treatment.

    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 posted22 Nov 2019
  2. Study start20 Nov 2019
  3. Primary completion30 Jul 2022 (estimated)
  4. Study completion30 Dec 2022 (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
Model description
A Phase II Single-arm, Open-label Study
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04174781
Sponsor's protocol ID
CISLD-5
Status last verified
Jun 2022
First submitted
20 Nov 2019
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo C, Zhang J, Huang X, Chen Y, Sheng J, Huang X, Sun J, Xiao W, Sun K, Gao S, Que R, Shen Y, Zhang M, Wu J, Bai X, Liang T. Preoperative sintilimab plus transarterial chemoembolization for hepatocellular carcinoma exceeding the Milan criteria: A phase II trial. Hepatol Commun. 2023 Feb 9;7(3):e0054. doi: 10.1097/HC9.0000000000000054. eCollection 2023 Mar 1.

    PubMed 36757445

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab and DEB-TACE 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 12 inclusion and 12 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 9 Jun 2022. 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?

Progression Free Survival (PFS) per mRECIST (time frame: 36 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 NCT04174781, which also lists 1 linked publication.

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 9 Jun 2022.

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