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Neoadjuvant TherapyPhase 2NCT04588987

Neoadjuvant Carilizumab and Apatinib for Recurrent High-Grade Glioma

A Phase 2 study testing PD-1 in people with Neoadjuvant Therapy and Carilizumab, run by Sun Yat-sen 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 The sponsor has not verified this record for over two years, so it may be out of date.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

GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Neoadjuvant Therapy, Carilizumab, Apatinib
What is being tested?
PD-1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Oct 2020to May 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Age 18-70 years old, both male and female.
  • After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma.
  • Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator.
  • KPS score ≥60；
  • Life expectancy >12 weeks.
Show all 14Show fewer
  • Adequate organ function defined by:
  • HGB≥110g/L；
  • WBC≥3.0×109/L；NEUT≥1.5×109/L；
  • PLT ≥75×109/L；
  • <!-- -->
  • BIL≤1.5ULN；
  • ALT and AST≤2.0×ULN；
  • creatinine < 1.5 x ULN or estimated creatinine clearance≥50ml/min（using the Cockcroft-Gault formula）

Who cannot join

  • Presence of extracranial disease.
  • Previous treatment with a PD-1, PDL-1 or CTLA-4，VEGFR targeted therapy.
  • Pregnant or breastfeeding patients.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
  • Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
  • History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
  • Known drug or alcohol abuse.

Trial locations and contacts

1 site in 1 country.

Chen Zhong ping, PHD contact

020-8734009

chenzhp@sysucc.org.cn

Ke Chao, PHD contact

kechao@sysucc.org.cn

China1 site, 1 recruiting

  • Cancer center of Sun Yat sen University

    Guangzhou, Guangdong

    Ke Chao, PHD, kechao@sysucc.org.cn

    Ju xue, PHD, yangqy@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Study to Evaluate the Safety and Efficiency of Using the Neoadjuvant Therapy With Carilizumab and Apatinib in Patients With Recurrent High-Grade Glioma ：A Prospective, Randomized Study

GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.

Being tested
PD-1
Medical subject headings
Glioma

What participants receive

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

  • PD-1Biological

    Also called apatinib

    Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG

Study groups in NCT04588987
Study groupRoleWhat they receive
Neoadjuvant groupExperimentalPatients need to treat with PD-1 and apatinib before surgery. Sequential therapy with PD-1 and apatinib when patients accepted surgery.
Receives: Biological: PD-1
Adjuvant groupExperimentalBefore surgery, patients no need to treat with PD-1 and apatinib. Sequential therapy with PD-1 and apatinib when patients accepted surgery.
Receives: Biological: PD-1

What is being measured

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

  1. Overall survival (OS)

    Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment

    Measured: 3 years

Secondary outcomes (1)

  1. Progression-free survival(PFS)

    Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment

    Measured: 18 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 Oct 2020
  2. Study startOct 2020 (estimated)
  3. Primary completionOct 2023 (estimated)
  4. Study completionMay 2024 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04588987
Sponsor's protocol ID
MA-GBM-II-001
Status last verified
Oct 2020
First submitted
6 Sep 2020
Last updated
19 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 in people with Neoadjuvant Therapy and Carilizumab, run by Sun Yat-sen 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 14 inclusion and 7 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 19 Oct 2020. 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?

Contact Chen Zhong ping, PHD (020-8734009, chenzhp@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 3 years). 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 NCT04588987.

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 19 Oct 2020.

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