AzTrials
AzTrials

Brain MetastasesEarly Phase 1NCT04967027

Phase 1 Trial for Tumor Treating Field for Drug/Radiation Resistant Brain Metastases

A Early Phase 1 study testing ASCLU-300 TTF in people with Brain Metastases, run by Xiangya Hospital of Central South 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Brain Metastases
What is being tested?
ASCLU-300 TTF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteChina
Study dates
1 Aug 2020to 1 Dec 2022
Phase
Early Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients are diagnosed as brain metastases by Xiangya Hospital multidisciplinary team;
  • age from 18 to 65 year-old;
  • patients have been progressed from standard therapy (drug/radiation resistance)
  • KPS more than 70 score;
  • anticipated OS more than 3 months;
  • signed consent form.

Who cannot join

  • unable to take TTFields more than 18 hours each day;
  • unable to follow-up till progression;
  • the scalp wound is not well healed, the head skin condition is not good, the skull has a large area defect, or other situations that are not suitable for wearing electrodes
  • pregnant women;
  • last drug within 4 weeks, last radiation within 3 months, take other trials;
  • other heavy diseases like heavy infection;
Show all 9Show fewer
  • other condition: Such as breastfeeding, installation of cardiac pacemakers, brain stimulators, severe intracranial edema, increased intracranial pressure leading to midline structures exceeding 5 mm, optic nerve head edema, disturbance of consciousness, etc., allergies to conductive coupling agents, gels, etc.
  • blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT > 3 times the upper limit of normal; B. Total bilirubin> upper limit of normal value; C. Renal impairment: serum creatinine>1.7mg /dL (>150 mol/L); D. Coagulopathy: PT or APTT >1.5 times normal; E. Platelets counts < 100x10^9/L; F. Absolute neutrophils count < 1x10^9/L; G. Hemoglobin < 100g/L;
  • other conditions physicians not suggest to take the trial

Trial locations and contacts

1 site in 1 country.

Fangkun Liu, MD contact

8615874290600

liufangkun@csu.edu.cn

Liyang Zhang, MD contact

8613787118459

zhangliyang@csu.edu.cn

China1 site, 1 recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

    Zhixiong Liu, M.D., +8613607318785, zhixiongliu@csu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Safety and Tolerability of TTFields for Patients With Brain Metastases After the Standard Treatment Fails: a Prospective, Single-center, Single-arm Study

Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. Tumor treating fields (TTFields) is one of the standard combination treatment for GBM, and some researchers believe that TTFields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. In this study, the investigator attempts to evaluate the safety, and tolerability of TTFields in adult participants diagnosed with Drug/Radiation resistant BM.

Being tested
ASCLU-300 TTF
Keywords
Tumor Treating Fields; Brain metastases;
Medical subject headings
Brain Neoplasms

What participants receive

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

  • ASCLU-300 TTFDevice

    BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)

Study groups in NCT04967027
Study groupRoleWhat they receive
TTFields groupExperimentalpatients with brain metastases who have been resistant to drug or radiation therapy, to be treated by continuous TTFields treatment using the ASCLU-300 TTF device.
Receives: Device: ASCLU-300 TTF

What is being measured

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

  1. The treatment-related adverse events

    Number of patients who experienced a treatment-related adverse event.

    Measured: 12 months

  2. Time to Progression

    Time to progression of patients with brain metastases

    Measured: 12 months

  3. Overall Survival Rate

    Number of patients alive at 12 months

    Measured: 12 months

Timeline

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

  1. First posted19 Jul 2021
  2. Study start1 Aug 2020
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 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
Early Phase 1
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04967027
Sponsor's protocol ID
BM V1.0/2020-08-01
Status last verified
Jul 2021
First submitted
4 Jul 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: due to protect the patients' privacy, we have not yet decided to share each IPD, but we can share IPD once other researchers request upon approval by our Ethics Committee

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing ASCLU-300 TTF in people with Brain Metastases, run by Xiangya Hospital of Central South 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 6 inclusion and 9 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 2 Mar 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Contact Fangkun Liu, MD (8615874290600, liufangkun@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The treatment-related adverse events (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT04967027.

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 2 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in