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Unresectable Hepatocellular CarcinomaNCT06503250

A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization

An observational study of Unresectable Hepatocellular Carcinoma, run by Hoffmann-La Roche at 5 sites 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 is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of Atezo+Bev plus Transarterial Chemoembolization (TACE) among adult patients with unresectable hepatocellular carcinoma (HCC) in real-world clinical practice in China. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
Atezolizumab, Bevacizumab and Transarterial Chemoembolization
Type of treatment
Surgery or procedure
How many people
113 participants
Where
5 sitesChina
Study dates
19 Jul 2024to 27 Nov 2024
Phase
Observational
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

Study population: Study population will consist of adult patients with unresectable HCC who initiated Atezo+Bev plus TACE between 28 October 2020 and 31 December 2023 from approximately 3-5 study sites in China. Sites will be selected based on geographic representativeness, experience in clinical studies and HCC disease management.

Who may be able to join

  • Initiating both Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 regardless of sequencing, number of doses/cycles, and type of TACE
  • At least one dose of Atezo+Bev and one cycle of TACE spaced no longer than 4 weeks
  • Diagnosed with HCC and considered as unresectable by any of the below criteria:
  • Predicted insufficient future liver remnant volume (FLRV) after liver resection, OR
  • Predicted unattainable safe negative tumor margin resection, i.e., R0 resection, OR
  • "Unresectable" directly documented in the medical records

Who cannot join

  • No visit record after initiating both Atezo+Bev and TACE
  • Treated with other systemic therapy or resection against HCC
  • Diagnosed with concomitant cancer except for basal cell carcinoma
  • Advanced portal vein tumor thrombosis (PVTT) as defined by: Grade Vp 4, Cheng's Classification Type III or IV, or presence of a tumor thrombus in the main trunk of the portal vein, a portal vein branch contralateral to the primarily involved lobe, or superior mesenteric vein
  • China Liver Cancer (CNLC) Stage IIIb, or history of extrahepatic metastasis
  • Terminal-stage HCC

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510630

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Tianjin First Central Hospital

    Tianjin, DUMMY_VALUE

  • The First Affiliated Hospital of Xian Jiao Tong University

    Xi'an, 710061

Other trials in China

About this study

Official title: Effectiveness and Safety of Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization as Conversion Therapy Among Patients With Initially Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice in China

This is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of Atezo+Bev plus Transarterial Chemoembolization (TACE) among adult patients with unresectable hepatocellular carcinoma (HCC) in real-world clinical practice in China. Eligible patients diagnosed with unresectable HCC initiating the Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 will be included in this study.

Being tested
Atezolizumab, Bevacizumab, Transarterial Chemoembolization

What participants receive

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

  • AtezolizumabDrug

    Also called Tecentriq

    Observational Study

  • BevacizumabDrug

    Also called Avastin

    Observational Study

  • Transarterial ChemoembolizationRadiation

    Also called TACE

    Observational Study

Study groups in NCT06503250
Study groupRoleWhat they receive
Retrospective CohortSecondary data from medical records of approx 5 sites across China will be utilized. Patient identification period is between 28 Oct 2020 to 31 Dec 2023. The index date is defined as the earlier date of initiating Atezo+Bev or TACE after the initial diagnosis of unresectable HCC. Baseline period is defined as 60 days prior to the index date. Observation period is defined as the period from the index date until death, latest visit record during retrospective observation period, diagnosis of other primary cancer (except basal cell carcinoma), or 31 March 2024, whichever occurs first.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Radiation: Transarterial Chemoembolization

What is being measured

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

  1. Median Time to Real-World Progression-Free Survival (rwPFS)

    rwPFS is defined as time from the index date to the first evidence of clinician-assessed progressive disease (may include but are not limited to local tumor progression, disease recurrence, new metastasis, or clinical progression anchored by clinicians) or death from any cause.

    Measured: up to approximately 12 months

Secondary outcomes (6)

  1. Median Time to Real-World Overall Survival (rwOS)

    rwOS is defined as time from the index date to death from any cause.

    Measured: up to approximately 3 years

  2. Median Time to Real-World Overall Response Rate (rwORR)

    rwORR is defined as the percentage of patients who achieved complete response (CR) or partial response (PR) after the initiation of both Atezo+Bev and TACE among patients with at least one response assessment result after the initiation of both Atezo+Bev and TACE, with reference to the assessment of tumor lesions within 60 days prior to the later initiation of Atezo+Bev or TACE.

    Measured: up to approximately 3 years

  3. Percentage of Participants with Serum Alpha-Fetoprotein (AFP) Reduction

    AFP reduction is defined as > 50% reduction in AFP level after 3 months (± 4 weeks) of the later initiation of Atezo+Bev or TACE.

    Measured: up to approximately 4 years

  4. Percentage of Participants with Prothrombin Induced by the Absence of Vitamin K or Antagonist-II (PIVKA-II) Reduction:

    PIVKA-II reduction is defined as > 50% reduction in PIVKA-II level after 3 months (± 4 weeks) of the later initiation of Atezo+Bev or TACE.

    Measured: up to approximately 4 years

  5. Percentage of Participants with Surgical Resection

    Conversion rate (surgical resection) is defined as the percentage of patients who underwent surgical resection of tumor among patients who completed the Atezo+Bev plus TACE treatment by the end of observation period.

    Measured: up to approximately 4 years

  6. Percentage of Participants with Adverse Events

    The adverse events of interest include liver function abnormality, renal function abnormality, hemorrhage, hypertension, hepatitis virus reactivation and immune-related adverse events.

    Measured: up to approximately 4 years

Timeline

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

  1. First posted16 Jul 2024
  2. Study start19 Jul 2024
  3. Primary completion27 Nov 2024
  4. Study completion27 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06503250
Sponsor's protocol ID
ML45337
Status last verified
Mar 2025
First submitted
10 Jul 2024
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

Questions about this trial

What is this clinical trial studying?

An observational study of Unresectable Hepatocellular Carcinoma, run by Hoffmann-La Roche at 5 sites 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 6 inclusion and 6 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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.

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?

Median Time to Real-World Progression-Free Survival (rwPFS) (time frame: up to approximately 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 NCT06503250.

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 21 Mar 2025.

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