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Nasopharyngeal CarcinomaPhase 2NCT04398056

Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab in the De Novo Metastatic Nasopharyngeal Carcinoma

A Phase 2 study testing Chemotherapy plus radiotherapy and Toripalimab in people with Nasopharyngeal Carcinoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 preliminarily evaluate the efficacy and safety of chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab for the de novo metastatic 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?
Chemotherapy plus radiotherapy and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
1 Apr 2019to 1 Jul 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Had histopathologically confirmed metastatic NPC that was diagnosed as stage IVb NPC as defined by the AJCC, 8th edition;
  • Patients evaluated to have a complete response (CR) or partial response (PR) by an imaging study after three cycles of cisplatin plus 5-fluorouracil (PF) chemotherapy;
  • Patients who did not receive any previous systemic chemotherapy;
  • Patients with a Karnofsky performance status (KPS) score of at least 70;
  • Patients with adequate organ function (white blood cell count of at least 4.0x109 per L; absolute neutrophil of at least 2.0x109 per L; hemoglobin concentrations of at least 90 g/L; platelet cell count of at least 100 x109 per L; aspartate transaminase and alanine transaminase levels less than 2.5 times the upper limit of the normal value; and creatinine clearance rate of at least 60 mL/min);
  • Patients who provided written informed consent;
  • Patients who agree to regular follow-up visits.

Who cannot join

  • Patients with recurrent mNPC who received prior definitive radiotherapy/chemoradiotherapy;
  • Patients with life-threatening medical disorders;
  • Patients who were pregnant or breastfeeding;
  • Patients with other invasive malignant diseases within the past 5 years, other than excised basal-cell skin carcinoma, cervical carcinoma in situ, superficial bladder tumors (Ta, Tis, and T1);
  • Patients with serious comorbidities.
  • Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval;
Show all 18Show fewer
  • Known history of hypersensitivity to any components of the Toripalimab formulation;
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
  • Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
  • Uncontrolled clinically significant medical condition, including but not limited to the following:
  • congestive heart failure (New York Health Authority Class \> 2);
  • unstable angina;
  • myocardial infarction within the past 12 months;
  • clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
  • Active infection or an unexplained fever; 38.5℃ during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
  • History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease;
  • Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results;
  • Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou

Other trials in China

About this study

Official title: Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab for the de Novo Metastatic Nasopharyngeal Carcinoma: a Single Center, Phase II Clinical Trial.

The purpose of this study is to preliminarily evaluate the efficacy and safety of chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab for the de novo metastatic nasopharyngeal carcinoma.

Read the detailed description

This is a single center , single arm, phase II study. All eligible patients with the de novo metastatic NPC are treated with chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab. The primary objective of this study is to assess objective response rate of chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma . The secondary objective is to assess progression free survival, and Adverse events.

Being tested
Chemotherapy plus radiotherapy and Toripalimab
Keywords
de novo nasopharyngeal carcinoma, radiotherapy, PD-1
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Chemotherapy plus radiotherapy and ToripalimabDrug

    1. Chemotherapy: The PF regimen included 5 g/m2 5-fluorouracil via a continuous intravenous infusion over 120 h and an intravenous administration of 100 mg/m2 cisplatin on day 1 for a maximum of six cycles.
    2. Radiotherapy, intensity-modulated radiation therapy (IMRT), PTVnx:66-70Gy/30-33F; PTVnd:66～70Gy/30～33F; PTV1:60～64Gy/30～33F; PTV2:50～54Gy/30～33F, 5 fractions per week, for 6 weeks
    3. Toripalimab 240mg every three weeks (Q3W) began on the first day of radiotherapy until an intolerable toxicity, or disease progression, or withdrawal of consent, or the investigator determines that he or she has to withdraw from treatment, or has been treated for up to 2 years.
Study groups in NCT04398056
Study groupRoleWhat they receive
Chemotherapy plus radiotherapy and ToripalimabExperimentalPatients were treated with PF chemotherapy for a maximum of six cycles followed by loco-regional radiotherapy combined with toripalimab.
Receives: Drug: Chemotherapy plus radiotherapy and Toripalimab

What is being measured

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

  1. Objective Response Rate

    The proportion of patients who achieved an objective response, defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;

    Measured: 1 year

Secondary outcomes (3)

  1. Disease Control Rate

    The proportion of patients who achieved disease control, defined as those with RECIST-defined objective response or stable disease

    Measured: 1 year

  2. Progression-free survival

    The time is defined from the enrolment to RECISTdefined progression or death from any cause

    Measured: 1 year

  3. The toxicity grade will be assessed according to CTCAE 5.0.

    Safety profiles

    Measured: 1 year

Timeline

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

  1. First posted21 May 2020
  2. Study start1 Apr 2019
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 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
Not applicable
Intervention model
Single group
Model description
This study used Simon's two-stage design. The main purpose of the study was to determine the objective response rates (PR+CR) of local-regional radiotherapy combined with Toripalimab followed by systemic chemotherapy for de novo metastatic nasopharyngeal carcinoma.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04398056
Sponsor's protocol ID
SYSUCC2019
Status last verified
Jul 2022
First submitted
6 May 2020
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen SY, Duan XT, Li HF, Peng L, Wang ZQ, Xu GQ, Hua YJ, Zou X, You R, Ouyang YF, Liu YP, Gu CM, Yang Q, Jiang R, Zhang MX, Lin M, Xie YL, Lin C, Ding X, Xie RQ, Duan CY, Zhang WJ, Huang PY, Chen MY. Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma: A phase II trial. Cell Rep Med. 2023 Nov 21;4(11):101279. doi: 10.1016/j.xcrm.2023.101279. Epub 2023 Nov 10.

    PubMed 37951218

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy plus radiotherapy and Toripalimab 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 7 inclusion and 18 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 6 Jul 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?

Objective Response Rate (time frame: 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 NCT04398056, 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 6 Jul 2022.

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