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Nasopharyngeal CarcinomaPhase 3NCT04453813

Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

A Phase 3 study testing Toripalimab plus concurrent chemo-radiotherapy and Concurrent chemo-radiotherapy in people with Nasopharyngeal Carcinoma and Chemotherapy, run by Sun Yat-sen University at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Toripalimab plus concurrent chemo-radiotherapy and Concurrent chemo-radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
6 sitesChina
Study dates
3 Jul 2020to Jul 2027
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed recurrent nasopharyngeal carcinoma.
  • The recurrence time is more than 12 months from the end of the first course of radiotherapy.
  • Tumor staged as rT2-4N0-3M0，rII-IVa (according to the 8th AJCC edition).
  • Subjects must have a measurable disease by CT or MRI per RECIST 1.1 criteria.
  • Karnofsky scale (KPS)≥70.
  • Normal bone marrow function.
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  • Normal liver and kidney function:
  • total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
  • creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
  • Given written informed consent.

Who cannot join

  • Resectable nasopharyngeal diseases: rT2 (the tumour is confined in the superficial parapharyngeal spacer and is more than 0.5cm from the internal carotid artery) and rT3 (the tumour is confined in the base wall of the sphenoid sinus and is more than 0.5cm from the internal carotid artery and cavernous sinus).
  • The patients are suffering from severe nasopharyngeal necrosis, radiation induced brain injury, and fibrosis of the neck et. al, who are evaluated as unsuitable for secondary radiotherapy by the researchers.
  • 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.
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  • The laboratory examination value does not meet the relevant standards within 7 days before enrollment
  • 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 with HBV DNA copy number of ≥1000cps/ml 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

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

Ming-Yuan Chen, MD, PhD contact

: 86-20-87343624

chmingy@mail.sysu.edu.cn

Rui You, MD, PhD contact

86-13580439820

yourui@sysucc.org.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ming-Yuan Chen, MD, PhD, 86-20-8734-3361, chmingy@mail.sysu.edu.cn

    Ming-Yuan Chen, MD, PhD

    Recruiting

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Dong-Ping Chen, MD, 86-13302215492, chen_dpgz@163.com

    Dong-Ping Chen, MD

    Not yet recruiting

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512025

    Su-Ming Pan, MD, 86-13826331948

    Su-Ming Pan, MD

    Not yet recruiting

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi, 543002

    Jin-Hui Liang, MD, 86-13878480806

    Jin-Hui Liang, MD

    Recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528403

    Feng Lei, MD, 86-18933345382, 13528227676@163.com

    Feng Lei, MD

    Not yet recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Zhi-Gang Liu, MD, PhD, 86-18627585860

    Zhi-Gang Liu, MD, PhD

    Not yet recruiting

Other trials in China

About this study

Official title: A Multicenter Randomized Clinical Phase 3 Trial of Toripalimab Plus Concurrent Chemo-radiotherapy vs Concurrent Chemo-radiotherapy Alone for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.

Read the detailed description

Through multicenter, open-label, randomised clinical trials, patients with unresectable locally recurrent nasopharyngeal carcinoma are randomized into concurrent chemo-radiotherapy plus concurrent and adjuvant PD-1 treatment group and concurrent chemo-radiotherapy alone group. The efficacy and safety of patients between these two groups are compared.

Being tested
Toripalimab plus concurrent chemo-radiotherapy, Concurrent chemo-radiotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Toripalimab plus concurrent chemo-radiotherapyDrug

    1. Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of toripalimab are concurrently used during radiotherapy and other 9 cycles of toripalimab are used after the end of radiotherapy. (A total of 11 cycles).
    2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
    3. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy

  • Concurrent chemo-radiotherapyDrug

    1. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
    2. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy
Study groups in NCT04453813
Study groupRoleWhat they receive
Toripalimab plus concurrent chemo-radiotherapy armExperimentalConcurrent chemo-radiotherapy plus concurrent and adjuvant toripalimab.
Receives: Drug: Toripalimab plus concurrent chemo-radiotherapy
Concurrent chemo-radiotherapy armActive comparatorConcurrent chemo-radiotherapy alone.
Receives: Drug: Concurrent chemo-radiotherapy

What is being measured

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

  1. Progress-free survival (PFS)

    Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

    Measured: 3 years

Secondary outcomes (7)

  1. Overall Survival (OS)

    Defined as the time interval from randomization to death due to any cause.

    Measured: 3 years

  2. Distant Metastasis-Free Survival (DMFS)

    Defined as the time interval from randomisation to the date of first distant metastases.

    Measured: 3 years

  3. Locoregional Relapse-Free Survival (LRRFS)

    Defined as the time from randomisation to the date of first locoregional relapse.

    Measured: 3 years

  4. Incidence of treatment related acute complications

    The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: up to 1 years

  5. Incidence of treatment related late complications

    The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

    Measured: up to 3 years

  6. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

    Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

    Measured: up to 3 years

  7. Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

    Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment.

    Measured: up to 3 years

Timeline

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

  1. First posted1 Jul 2020
  2. Study start3 Jul 2020
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04453813
Sponsor's protocol ID
SYSUCC-MYC-2020-2101
Status last verified
Sep 2020
First submitted
27 Jun 2020
Last updated
28 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Toripalimab plus concurrent chemo-radiotherapy and Concurrent chemo-radiotherapy in people with Nasopharyngeal Carcinoma and Chemotherapy, run by Sun Yat-sen University at 6 sites 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Ming-Yuan Chen, MD, PhD (: 86-20-87343624, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress-free survival (PFS) (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 NCT04453813.

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 28 Sep 2020.

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