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Nasopharyngeal CarcinomaPhase 2NCT04605562

Umbrella Biomarker-Guided Therapy in NPC

A Phase 2 study testing GP+DDP, Palbociclib and Intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a phase 2, open-label, umbrella study, with the purpose to evaluate the therapeutic efficacy and safety of chemoradiotherapy in combination with immunotherapy and/or targeted treatment in high-risk locoregionally advanced nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
GP+DDP, Palbociclib and Intensity-modulated radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
1 siteChina
Study dates
Jun 2022to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age: 18 to 65;
  • Pathological type: non-keratinizing carcinoma (World Health Organization criteria);
  • Diagnosed with LANPC (T4N1, T1-4N2-3) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC];
  • ECOG performance score: 0 to 1;
  • Normal bone marrow function: white blood cell count > 4×109/L, hemoglobin > 90g/L, platelet count > 100×109/L;
  • Normal values of thyroid function, amylase and lipase examination, pituitary function, inflammation and infection indicators, myocardial enzymes, and ECG results. For patients older than 50 years with a smoking history, normal lung function are required. Patients with abnormal ECG and/or a history of vascular disease (but not meeting the exclusion criteria listed in the exclusion criteria 7) need further testing and require normal results of myocardial function and color Doppler ultrasound.
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  • Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine transaminase and aspartate transaminase ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance rate ≥ 60 ml/min;
  • Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;
  • Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.

Who cannot join

  • Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA > 1×10E3 copies/ml; anti-hepatitis C virus positive;
  • Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
  • Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment; history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved;
  • Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);
  • Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
  • Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible;
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  • Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2); 2) unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;
  • Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
  • Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
  • Allergy to macromolecular protein preparations, or any component of the intervention drugs;
  • Active infection requiring systemic treatment;
  • History of organ transplantation;
  • History of psychotropic disease, alcoholism or drug abuse; other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Precision Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma Based on Molecular Immune Subtyping: an Umbrella Trial

This is a phase 2, open-label, umbrella study, with the purpose to evaluate the therapeutic efficacy and safety of chemoradiotherapy in combination with immunotherapy and/or targeted treatment in high-risk locoregionally advanced nasopharyngeal carcinoma. The specific grouping of patients' depends on the SYSUCC immune subtyping based on 100+ gene panel testing.

Read the detailed description

This is a phase 2, open-label, umbrella study, with the purpose to evaluate the therapeutic efficacy and safety of chemoradiotherapy in combination with immunotherapy and/or targeted treatment in high-risk locoregionally advanced nasopharyngeal carcinoma. The specific grouping of patients' depends on the SYSUCC immune subtyping based on 100+ gene panel testing. The molecular subgroups include the Active, Evaded and non-Immune Subtypes. New treatment arms may be added and/or existing treatment arms may be closed during the study course on the basis of ongoing efficacy and safety as well as the current treatments available.

Being tested
GP+DDP, Palbociclib, Intensity-modulated radiotherapy, PD-1 blocking antibody, Galunisertib
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • GP+DDPDrug

    Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles; induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

  • PalbociclibDrug

    Administered orally

  • Intensity-modulated radiotherapyRadiation

    Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day

  • PD-1 blocking antibodyDrug

    Administered every 3 weeks

  • GalunisertibDrug

    Administered orally

Study groups in NCT04605562
Study groupRoleWhat they receive
IC+CCRT with palbociclibExperimentalIf patients were non-Immune Subtype.
Receives: Drug: GP+DDP; Drug: Palbociclib; Radiation: Intensity-modulated radiotherapy
IC+CCRT with galunisertib and PD-1 blocking antibodyExperimentalIf patients were Evaded Immune Subtype.
Receives: Drug: GP+DDP; Radiation: Intensity-modulated radiotherapy; Drug: PD-1 blocking antibody; Drug: Galunisertib
IC+CCRT with PD-1 blocking antibodyExperimentalIf patients were Active Immune Subtype.
Receives: Drug: GP+DDP; Radiation: Intensity-modulated radiotherapy; Drug: PD-1 blocking antibody

What is being measured

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

  1. Failure-free survival (FFS)

    Failure-free survival is measured from day of diagnosis until treatment failure, death from any cause, or last follow-up visit, whichever occurred first

    Measured: 3-year

Secondary outcomes (4)

  1. Overall survival (OS)

    Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive

    Measured: 3-year

  2. Distant failure-free survival (DFFS)

    Distant failure-free survival is measured from day of diagnosis until distant metastasis

    Measured: 3-year

  3. Incidence rate of investigator-reported adverse events (AEs)

    Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0

    Measured: 3-year

  4. Incidence rate of patient-reported adverse events (AEs)

    Analysis of patient-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by patients themselves

    Measured: 3-year

Timeline

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

  1. First posted28 Oct 2020
  2. Study startJun 2022 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04605562
Sponsor's protocol ID
SZR2019-069
Status last verified
Sep 2021
First submitted
22 Oct 2020
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GP+DDP, Palbociclib and Intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma, 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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 5 Sep 2021. 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?

This study is still under way. Results are not available in the source record yet.

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?

Failure-free survival (FFS) (time frame: 3-year). 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 NCT04605562.

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 5 Sep 2021.

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Umbrella Biomarker-Guided Therapy in NPC (NCT04605562) | AzTrials