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Nasopharyngeal NeoplasmsPhase 2NCT04446663

Toripalimab Combined With Chemoradiotherapy in Patients With Locoregionally-advanced Nasopharyngeal Carcinoma

A Phase 2 study testing Toripalimab, Albumin-bound Paclitaxel and Cisplatin in people with Nasopharyngeal Neoplasms, run by First People's Hospital of Foshan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open-label, parallel controlled, phase IIa exploratory study that evaluates the efficacy and safety of Toripalimab (PD-1 Antibody) combined with induction chemotherapy （Albumin-bound paclitaxel and cisplatin ）and concurrent chemoradiotherapy in the treatment of nasopharyngeal carcinoma and explores the… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Neoplasms
What is being tested?
Toripalimab, Albumin-bound Paclitaxel and Cisplatin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
15 Jul 2020to 15 Dec 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

  • Only the patients meeting all the following criteria can be eligible to participate in the trial:
  • Fully understand this study and voluntarily sign the informed consent form (ICF); have good compliance;
  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ;
  • locoregionally advanced nasopharyngeal carcinoma (LANPC)（T3-4N0-1M0/T1-4N2-3M0）;
  • Age 18 to 70 years;
  • ECOG PS 0-1;
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  • The laboratory examination results before enrollment must meet the following standards:
  • Neutrophils ≥1.5 × 109 / L;
  • Platelets ≥100 × 109 / L;
  • Hemoglobin ≥90g / L (no infusion of concentrated red blood cells within 4 weeks);
  • Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL / min;
  • Total serum bilirubin ≤ 1.5 × ULN;
  • AST and ALT ≤ 2.5 × ULN;
  • The ULN of coagulation parameters APTT is not extended for more than 10 seconds, and the ULN of PT is not extended for more than 3 seconds;
  • Women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraception during drug use and within 1 year after the last dose；Men whose female partners have the ability to become pregnant must agree to use reliable contraception within 1 year from the screening visit to the last Toripalimab administration.

Who cannot join

  • Women of child-bearing potential are pregnant or breastfeeding ;
  • Have known allergy to large molecule protein products or any compound of Toripalimab;
  • Central nervous system metastases with clinical symptoms accompanied by cerebral edema, requiring hormone intervention, or progression of brain metastases;
  • Prior malignancy within 5 years, except carcinoma in situ of the cervix, adequately treated basal cell carcinoma of the skin and papillary thyroid carcinoma;
  • Received any of the following treatments:
  • Patients who have been treated with inhibitors of immune regulation (CTLA-4, PD-1, PD-L1, etc.);
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  • Received any research drug within 4 weeks before the first administration of the drug;
  • Join another clinical study at the same time, unless it is an observational (non-interventional) study or intervention study during follow-up;
  • Within 28 days before signing the informed consent, received an equivalent dose of >10 mg prednisone/day or other immunosuppressive therapy, and a systemic hormone dose of ≤10 mg prednisone/day or inhaled/topical corticosteroids;
  • Have been vaccinated with anti-tumor vaccines or have been vaccinated with live vaccines within 4 weeks before the first administration of study drugs;
  • Have undergone major surgery or severe trauma within 4 weeks before the first administration of study drugs;
  • Uncontrolled clinical symptoms or diseases of the heart, such as: (1) Heart failure above NYHA level II (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Clinically supraventricular or Patients with ventricular arrhythmias requiring clinical intervention;
  • Serious infections (CTCAE>2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infection comorbidities that require hospitalization; baseline chest imaging examinations suggest active lung inflammation . The symptoms and signs of infection exist within 2 weeks before the first dose or require oral or intravenous antibiotic use (excluding prophylactic antibiotic use);
  • Have a history of interstitial lung disease and non-infectious pneumonia;
  • Have active tuberculosis infection, or have a history of active tuberculosis infection within 1 year before enrollment, or have active tuberculosis infection one year ago but have not been formally treated;
  • Have active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to These diseases and syndromes); Autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with stabilized doses of insulin; but excluding vitiligo or cured childhood asthma/allergy who do not require any intervention in adults;
  • A history of HIV infection, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation;
  • Have active hepatitis HBsAg positive and HBV DNA ≥2000IU/ml or 1000 copies/ml, hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection limit);
  • Known history of psychotropic substance abuse, alcoholism and drug abuse;
  • Any other disease or condition of clinical significance that the investigator believes may affect protocol compliance, or affect the signing of an ICF, or is not suitable for participation in this clinical trial.

Trial locations and contacts

No sites are listed yet.

Guo Yi Zhang, Doctor contact

+86-0757-83162735

guoyizhff@163.com

About this study

Official title: Toripalimab Combined With Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma: an Open-label, Parallel Controlled, Phase IIa Study

This is an open-label, parallel controlled, phase IIa exploratory study that evaluates the efficacy and safety of Toripalimab (PD-1 Antibody) combined with induction chemotherapy （Albumin-bound paclitaxel and cisplatin ）and concurrent chemoradiotherapy in the treatment of nasopharyngeal carcinoma and explores the biomarkers that can predict the efficacy and toxicity of the treatment.

Being tested
Toripalimab, Albumin-bound Paclitaxel, Cisplatin, intensity-modulated radiotherapy
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

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

  • ToripalimabDrug

    Also called JS001

    Toripalimab 240mg ivdrip, every 3 weeks for 6 cycles, with 3 cycles combined with induction chemotherapy, 3 cycles combined with concurrent chemoradiotherapy

  • Albumin-bound PaclitaxelDrug

    Albumin-bound Paclitaxel 260 mg/m2, d1 of every cycle, every 3 weeks for 3 cycles before radiotherapy

  • CisplatinDrug

    Also called DDP

    Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiotherapy Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiotherapy

  • intensity-modulated radiotherapyRadiation

    Also called IMRT

    Definitive IMRT of ≥66 Gy will be given .

Study groups in NCT04446663
Study groupRoleWhat they receive
Toripalimab+induction chemotherapy +CCRTExperimentalPatients will receive induction chemotherapy with Albumin-bound paclitaxel (260 mg/m2, d1 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiotherapy. Then patients will receive definitive intensity-modulated radiotherapy (IMRT) of ≥66 Gy（2-2.2Gy/fx）.Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT . Toripalimab 240mg will be given every 3 weeks for 6 cycles, started on day 1 of induction chemotherapy
Receives: Drug: Toripalimab; Drug: Albumin-bound Paclitaxel; Drug: Cisplatin; Radiation: intensity-modulated radiotherapy
induction chemotherapy +CCRTActive comparatorPatients will receive induction chemotherapy with Albumin-bound paclitaxel (260 mg/m2, d1 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiotherapy. Then patients will receive definitive intensity-modulated radiotherapy (IMRT) of ≥66 Gy（2-2.2Gy/fx）.Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT .
Receives: Drug: Albumin-bound Paclitaxel; Drug: Cisplatin; Radiation: intensity-modulated radiotherapy

What is being measured

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

  1. Adverse events

    Incidence of adverse events as assessed by CTCAE v5.0

    Measured: 2 years

Secondary outcomes (5)

  1. Overall survival (OS)

    calculated from randomization to the date of death from any cause.

    Measured: 3 years

  2. Distant failure-free survival (DFFS)

    calculated from randomization to the date of first distant metastasis.

    Measured: 3 years

  3. Locoregional failure-free survival (LRFFS)

    calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence

    Measured: 3 years

  4. Overall response rate （ORR）and Complete response rate（CR）

    Defined as percentage of participants achieving complete response (CR) and partial response (PR) according to the RECIST 1.1.

    Measured: 2 years

  5. Quality of life (QoL)

    The change of QoL from randomization to 12 months after chemoradiation. The European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual: 1. Estimate the average of the questions that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardise the raw score, so that scores range from 0 to 100. Thus, a high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high QoL, but a high score for a symptom scale represents a high level of problems.

    Measured: 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 posted25 Jun 2020
  2. Study start15 Jul 2020 (estimated)
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion15 Dec 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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04446663
Sponsor's protocol ID
JS001-ISS-CO185
Status last verified
Jun 2020
First submitted
19 Jun 2020
Last updated
25 Jun 2020
Results posted
No
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 Toripalimab, Albumin-bound Paclitaxel and Cisplatin in people with Nasopharyngeal Neoplasms, run by First People's Hospital of Foshan.

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 15 inclusion and 20 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Guo Yi Zhang, Doctor (+86-0757-83162735, guoyizhff@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 2 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 NCT04446663.

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 25 Jun 2020.

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