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Hepatocellular CarcinomaPhase 2NCT04842565

cTACE Plus Sintilimab for Unresectable Intermediate-stage HCC With Beyond Up-to-seven Criteria

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

This study will evaluate the efficacy and safety of Sintilimab plus Transcatheter arterial chemoembolization (TACE) in participants with Intermediate-stage unresectable hepatocellular carcinoma with Beyond Up-to-seven Criteria. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sintilimab and TACE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 May 2021to 1 May 2023
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥20 and ≤75 years old
  • Clinically diagnosed or pathologically confirmed advanced hepatocellular carcinoma. ( Fibrolamellae and mixed hepatocellular/cholangiocarcinoma subtypes are not included)
  • CNLC stage IIa/IIb or BCLC stage B, not eligible for resection or local ablation, beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor [in cm] and the number of tumors)
  • Newly diagnosed or recurrent more than half a year after radical surgery
  • No prior TACE treatment,
  • Child-Pugh A, ECOG PS: 0-1
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  • Patients with chronic HBV infection must have HBV DNA viral load < 500 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
  • At least one measurable site of disease as defined by modified RECIST (mRECIST) and RECICL criteria with spiral CT scan or MRI.
  • Life expectancy of at least 3 months.
  • Adequate blood count, liver-enzymes, and renal function: Haemoglobin ≥ 8.5 g/dL, absolute neutrophil count ≥ 1,500/L, platelets ≥70 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 )
  • Patients are 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.
  • Normal T3 and T4. (T3 and T4 controlled in the normal range through treatment is also eligible.)
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.

Who cannot join

  • Diffuse HCC or presence of vascular invasion or extrahepatic spread.
  • The patient suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
  • Known history of hepatic encephalopathy within 6 months
  • Known history of cardiac disease within 12 months before the first dose of study drug.
  • Clinically significant hemoptysis or tumor bleeding of any reason within 2 weeks before the first dose of study drug.
  • Severe unhealed wounds, ulcers, or fractures
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  • Prior systemic anti-cancer therapy.
  • Prior treatment with TACE.
  • Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
  • Any active autoimmune disease or a history of autoimmune disease.
  • Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
  • History of allogeneic tissue/solid organ transplant.
  • Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein content> 1.0 g.
  • 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 patients who are pregnant, breast-feeding.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Phase II Trial of cTACE Plus Sintilimab for Treatment of Unresectable Intermediate-stage HCC With Beyond Up-to-seven Criteria

This study will evaluate the efficacy and safety of Sintilimab plus Transcatheter arterial chemoembolization (TACE) in participants with Intermediate-stage unresectable hepatocellular carcinoma with Beyond Up-to-seven Criteria.

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 (200mg ivdrip D1 Q3W)

  • TACEDevice

    TACE will be performed by clinical demand, the interval between two TACEs is not less than 4 weeks.

Study groups in NCT04842565
Study groupRoleWhat they receive
TACE+SintilimabExperimentalNot described
Receives: Drug: Sintilimab; Device: TACE

What is being measured

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

  1. Progression-free survival time (mPFS) (mRECIST)

    The progression-free survival time (mPFS) is defined as the date from the first TACE to the date of first documented disease progression as assessed by mRECIST or death.

    Measured: Up to approximately 24 months

Secondary outcomes (5)

  1. Overall Survival (OS)

    Overall survival (OS) after enrollment is defined as the first TACE to death from any cause.

    Measured: Up to approximately 24 months

  2. Percentage of Participants With Adverse Events

    Number of participants with treatment-related adverse events as assessed by CTCAE V5.0

    Measured: Up to approximately 24 months

  3. Objective response rate (ORR) by RECIST 1.1 and mRECIST

    Objective Response Rate according to mRECIST and RECIST 1.1 for HCC

    Measured: Up to approximately 24 months

  4. Progression-free survival time (mPFS) (RECICL)

    The progression-free survival time (mPFS) is defined as the first time TACE to the date of first documented disease progression as assessed by RECICL or death, whichever comes earlier.

    Measured: Up to approximately 24 months

  5. Time to Progression (TTP)

    Time to Progression (TTP) is defined as the time from first TACE to the date of the first documented tumor progression according to the definition above.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted13 Apr 2021
  2. Study start1 May 2021
  3. Primary completion1 May 2022
  4. Study completion1 May 2023

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04842565
Sponsor's protocol ID
B2020-178R
Status last verified
May 2024
First submitted
8 Apr 2021
Last updated
22 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li L, Xu X, Wang W, Huang P, Yu L, Ren Z, Fan J, Zhou J, Zhang L, Wang Z. Safety and efficacy of PD-1 inhibitor (sintilimab) combined with transarterial chemoembolization as the initial treatment in patients with intermediate-stage hepatocellular carcinoma beyond up-to-seven criteria. J Immunother Cancer. 2025 Jan 16;13(1):e010035. doi: 10.1136/jitc-2024-010035.

    PubMed 39824532

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 13 inclusion and 15 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 22 May 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?

Progression-free survival time (mPFS) (mRECIST) (time frame: Up to approximately 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 NCT04842565, 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 22 May 2024.

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