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Hepatocellular Carcinoma Non-resectablePhase 2NCT04511455

Cabozantinib for Patients with Hepatocellular Carcinoma (HCC) Refractory to First Line Treatment

A Phase 2 study testing Cabozantinib in people with Hepatocellular Carcinoma Non-resectable and Metastatic Hepatocellular Carcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 10 sites in Germany.

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

Patients suffering from advanced stage hepatocellular carcinoma (HCC) who have shown disease progression during lenvatinib-based first line treatment, will be enrolled in this trial. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cabozantinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
10 sitesGermany
Study dates
8 Dec 2020to 31 Dec 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

  • Fully-informed written consent.
  • Males and females ≥ 18 years of age.
  • There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.
  • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by guideline criteria in cirrhotic patients
  • Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.
  • Patients who have shown progressive disease during or after first line therapy OR patients must have had their treatment interrupted due to the level of toxicities AND cabozantinib therapy is intended as second line therapy.
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  • ECOG performance status ≤ 2.
  • Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade 1 prior to study entry, with the exception of alopecia.
  • For women of childbearing potential and men who are sexually active with women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods.

Who cannot join

  • Unwillingness to give informed consent for participation in the study.
  • Prior sorafenib treatment.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after last dose of study treatment.
  • Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
  • Significant portal hypertension (moderate or severe ascites).
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
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  • Liver cirrhosis Child-Pugh B with > 7 points and Child-Pugh C.
  • Severely impaired kidney function.
  • History of encephalopathy in past 12 months, if not completely regressive or more than one episode within the last 6 months.
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
  • Baseline QTcF >500 ms.
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
  • Elevations of AST/ALT exceeding 5 X ULN.
  • Treatment with investigational systemic therapy within 28 days prior to initiation of study treatment.
  • Prior cabozantinib use.
  • Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
  • Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

  • Universitätsklinikum Köln

    Cologne, 50937

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • VK&K Studien

    Landshut, 84036

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Johanna Etienne Krankenhaus

    Neuss, 41462

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

About this study

Official title: A Phase II, Non-randomized, Single Arm, Translational Study of Cabozantinib for Patients with Hepatocellular Carcinoma (HCC) Refractory to First Line Treatment

Patients suffering from advanced stage hepatocellular carcinoma (HCC) who have shown disease progression during lenvatinib-based first line treatment, will be enrolled in this trial. Patients who progressed either during lenvatinib monotherapy or lenvatinib-IO (immuno-oncology) combination therapy will be eligible for study participation, whereas at least 50% of the enrolled patients should be in favor of lenvatinib monotherapy.

Read the detailed description

This is a open-label, single-arm, multicenter phase II trial for patients with locally advanced and/or metastatic and/or unresectable hepatocellular carcinoma (HCC).

Patients who have histologically proven or were clinically diagnosed (by guideline criteria in cirrhotic patients) with locally advanced or metastatic and/or unresectable HCC will be included to receive cabozantinib peroral 60 mg/day. A stepwise dose de-escalation schedule on individual level is available for patients with lower tolerability against cabozantinib.

The study treatment will be limited to a maximum of 12 months (including temporary interruptions).

Tumor tissue will be collected for accompanying research project. (Participation is optional for participant).

During treatment, clinical visits (blood cell counts, ECG, detection of toxicity) occur every four weeks during treatment phase. Safety will be monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported.

During treatment, tumor response will be assessed by the Investigator according to RECIST 1.1 (radiological imaging by CT and/or MRI of the chest, abdomen, pelvis and all other sites of disease every 10 weeks until end of treatment (EOT) and every 12 weeks during follow-up (FU), in case of EOT due to other reasons than progressive disease. Safety-FU visit and Survival FU visits will be assessed 30 days-, and every 12 weeks after EOT.

Being tested
Cabozantinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

Study groups in NCT04511455
Study groupRoleWhat they receive
ExperimentalExperimentalCabozantinib peroral 60 mg/day A stepwise dose de-escalation schedule on individual level is available for patients with lower tolerability against cabozantinib. The study treatment will be limited to a maximum of 12 months (including interruptions).
Receives: Drug: Cabozantinib

What is being measured

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

  1. Time-on-treatment

    Time on treatment will be assessed as time from date of first dose of cabozantinib intake till date of permanent discontinuation of treatment.

    Measured: at study end (approx. 30 months after FPI)

Secondary outcomes (10)

  1. Overall survival (OS)

    Survival rates will be assessed from the date of first dose of cabozantinib intake to the date of death from any cause using Kaplan-Meier methods.

    Measured: at 18 months after last patient randomized

  2. Progression free survival (PFS)

    Survival rates for the different time points will be determined using the Kaplan-Meier analysis and RECIST 1.1.

    Measured: at study end (approx. 18 months after last patient randomized)

  3. Objective response rate (ORR)

    Objective response rate will be defined as the proportion of subjects experiencing a confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1.

    Measured: at study end (approx. 18 months after last patient randomized)

  4. Duration of response

    Time from documentation of tumor response to disease progression.

    Measured: at study end (approx. 18 months after last patient randomized)

  5. Treatment exposure

    Time on treatment/dose intensity/dose reductions

    Measured: at study end (approx. 18 months after last patient randomized)

  6. Toxicity: o Treatment-related adverse events (TRAEs) o TRAE related treatment interruptions o TRAE related treatment modifications o TRAE related treatment discontinuations

    All observed toxicities and side effects will be graded according to NCI CTCAE v5.0 and the degree of association of each with the study treatment assessed and summarized.

    Measured: at study end (approx. 18 months after last patient randomized)

  7. Change in ECOG Performance Status

    Eastern Cooperative Oncology Group patient performance status (Grading from 0 to 5)

    Measured: at study end (approx. 18 months after last patient randomized)

  8. Change in ALBI Grade

    ALBI score = -0.085 × (albumin g/L) + 0.66 × l g(TBil μmol/L)

    Measured: at study end (approx. 18 months after last patient randomized)

  9. Change in Child Pugh Score

    Child-Pugh Classification Score (Grading from A to C)

    Measured: at study end (approx. 18 months after last patient randomized)

  10. Translational research

    Correlation of biomarkers potentially associated with clinical efficacy (OS, PFS and ORR) of cabozantinib by NGS Oncopanel analysis and VEGF module expression analysis.

    Measured: at study end (approx. 18 months after last patient randomized)

Timeline

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

  1. First posted13 Aug 2020
  2. Study start8 Dec 2020
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04511455
Sponsor's protocol ID
AURORA
Other IDs
2019-004728-39, AIO-HEP-0419/ass, IKF-t018, 2019
Status last verified
Jan 2025
First submitted
4 Aug 2020
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Hepatocellular Carcinoma Non-resectable and Metastatic Hepatocellular Carcinoma, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 10 sites in Germany.

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 9 inclusion and 20 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 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. 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?

Time-on-treatment (time frame: at study end (approx. 30 months after FPI)). 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 NCT04511455.

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 30 Jan 2025.

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