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Nasopharyngeal CarcinomaPhase 2NCT03854838

IMRT Combined With Toripalimab in Unresectable Locally Recurrent Nasopharyngeal Carcinoma.

A Phase 2 study testing Tolipalimab and Reirradiation in people with Nasopharyngeal Carcinoma and Nasopharyngeal Neoplasms, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to evaluate the efficacy and safety of intensity-modulated radiation therapy combined with toripalimab in patients with the unresectable locally recurrent nasopharyngeal carcinoma. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Tolipalimab and Reirradiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 May 2019to 1 Feb 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed Recurrent Nasopharyngeal Carcinoma ( the recurrence time was more than 12 months from the end of the first course of radiotherapy)
  • Patients with histologically confirmed nasopharyngeal carcinoma(WHO type II-III)
  • Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
  • Can provide either a newly obtained or archival tumor tissue sample.
  • Tumor staged as rT0-4N1-3M0 or T2-4N0M0，II-IVa (according to the 8th AJCC edition).
  • 18 Years to 65 Years
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  • Eastern Cooperative Oncology Group performance status ≤1
  • Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
  • Life expectancy ≥ 3months
  • Subjects must be willing to participate in the research and sign an informed consent form (ICF)
  • Female of child bearing potential, a negative urine or serum pregnancy test result within 72 h before study treatment. Participants of reproductive potential must be willing to use adequate contraception for the course of the study through 60 days after the last dose of Toripalimab.
  • Male subjects with WOCBP partner must be willing to use adequate contraception for the course of the study through 120 days after the last dose of Toripalimab.

Who cannot join

  • operable recurrence of nasopharyngeal cancer: rT1N0M0 rT2N0M0 (the tumour was confined in the superficial parapharyngeal spacer) rT3N0M0 (the tumour was confined in the base wall of the sphenoid sinus) rT0N1-3M0 (the tumour was not invasion into the cervical vertebrae, brachial plexus, deep muscles of the neck, or carotid artery)
  • Has known allergy to large molecule protein products or any compound of study therapy
  • Has known Subjects with other malignant tumors
  • Has any active autoimmune disease or history of autoimmune disease
  • Has a history of psychiatric substance abuse, alcoholism, or drug addiction;
  • the laboratory examination value does not meet the relevant standards within 7 days before enrollment
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  • Received a systematic Glucocorticoid therapy within 4 weeks of the first dose of study medication.
  • Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
  • Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
  • Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy) Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
  • Has a known history of human immunodeficiency virus (HIV).
  • Has hepatitis B surface antigen (HBsAg) positive or hepatitis C virus (HCV) antibody positive
  • Has received a live vaccine within 4 weeks of planned start of study therapy
  • Pregnancy or breast feeding

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Single Center 、Single Arm Phase I/II Clinical Trial of Intensity-modulated Radiotherapy Combined With Toripalimab in the Treating of Unresectable Locally Recurrent Nasopharyngeal Carcinoma.

The purpose of this study is to evaluate the efficacy and safety of intensity-modulated radiation therapy combined with toripalimab in patients with the unresectable locally recurrent nasopharyngeal carcinoma.

Read the detailed description

This is an open-label ,single center ,non-randomized, single arm exploratory study. All eligible patients presented with non-keratinizing NPC and stage rT0-4N1-3M0 /rT2-4N0M0 are assigned to receive IMRT combined with toripalimab.

Being tested
Tolipalimab, Reirradiation
Keywords
toripalimab, IMRT, Intensity-Modulated Radiation Therapy, PD-1
Medical subject headings
Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, Head and Neck Neoplasms

What participants receive

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

  • TolipalimabDrug

    Also called JS001

    Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks) will be administered as an intravenous infusion over 60 minutes.

  • ReirradiationRadiation

    intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks

Study groups in NCT03854838
Study groupRoleWhat they receive
Toripalimab +RadiotherapyExperimentalRadiotherapy, intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks. Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks ) will be administered as an intravenous infusion over 60 minutes.
Receives: Drug: Tolipalimab; Radiation: Reirradiation

What is being measured

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

  1. ORR

    Objective Response Rate

    Measured: Through study completion, an average of 1 year

Secondary outcomes (3)

  1. PFS

    Progression-Free Survival is defined as time interval from recruitment to tumor progression or censoring.

    Measured: up to 3 years

  2. OS

    Overall Survival is defined as time interval from recruitment to all-caused death or censoring.

    Measured: up to 3 years

  3. Incidence of Treatment-Emergent Adverse Events

    Adverse events (AE), Serious Adverse Event(SAE)

    Measured: Through study completion, an average of half a year

Timeline

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

  1. First posted26 Feb 2019
  2. Study start1 May 2019
  3. Primary completion1 Feb 2021
  4. Study completion1 Feb 2023 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03854838
Sponsor's protocol ID
2019-FXY-020
Status last verified
Apr 2022
First submitted
24 Feb 2019
Last updated
29 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hua Y, You R, Wang Z, Huang P, Lin M, Ouyang Y, Xie Y, Zou X, Liu Y, Duan C, Liu Y, Gu C, Liu R, Yang Q, Jiang R, Zhang M, Ding X, Chen S, Lin C, Sun R, Chen M. Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial. J Immunother Cancer. 2021 Nov;9(11):e003290. doi: 10.1136/jitc-2021-003290.

    PubMed 34782428

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tolipalimab and Reirradiation in people with Nasopharyngeal Carcinoma and Nasopharyngeal Neoplasms, 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 12 inclusion and 14 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 29 Apr 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?

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?

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?

ORR (time frame: Through study completion, an average of 1 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 NCT03854838, which also lists 1 linked publication.

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 29 Apr 2022.

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