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AzTrials

Nasopharyngeal CarcinomaPhase 2NCT05431764

Whole-target Consolidation Therapy Under Systemic Therapy for Oligometastatic Nasopharyngeal Carcinoma

A Phase 2 study testing Camrelizumab, gemcitabin, cisplatin and Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In this exploratory clinical trial, patients with newly diagnosed distant metastatic nasopharyngeal carcinoma were treated with gemcitabine+ cisplatin+PD-1 inhibitor regimen followed by whole-target radiotherapy (IMRT for local regional lesion, SBRT for distant metastasis) and PD-1 inhibitor long-term maintenance… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Camrelizumab, gemcitabin, cisplatin and Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
20 Jun 2022to 20 Jun 2026
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

  • Male or female; 18-70 years of age.
  • Had histopathologically confirmed nonkeratinizing metastatic NPC that was diagnosed as stage IVb NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary).
  • Patients who had not received anti-tumor therapy for nasopharyngeal cancer before this clinical trial.
  • Patients evaluated to have a partial response (PR) or stable disease (SD) by head and neck MRI and PET/CT after 3 months of locoregional radiotherapy, and the metastatic lesions were assessed as oligometastatic lesions (the number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3).
  • Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
  • ECOG performance status of 0 or 1.
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  • Maximum diameter of brain metastatic lesion no more than 3cm.
  • Maximum diameter of metastatic lesion (brain excluded) no more than 5cm.
  • Maximum diameter of bone metastatic lesion no more than 6cm if attending doctor decides it is safe to apply the treatment.
  • Life expectancy more than 6 months.

Who cannot join

  • History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.
  • chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.
  • Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord.
  • Patient with brain metastasis who needs decompression surgery.
  • Other malignancy or malignant hydrothorax.
  • Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.
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  • CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
  • Use of large dose corticosteroids within 4 weeks before study drug administration.
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.
  • Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening
  • 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.
  • Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
  • Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
  • Pregnancy or lactation.
  • Other ineligible patients according to attending doctor.

Trial locations and contacts

1 site in 1 country.

Ming-Yuan Chen, MD, PhD contact

86-20-8734-3361

chmingy@mail.sysu.edu.cn

Rui You, MD, PhD contact

86-13580439820

yourui@sysucc.org.cn

China1 site, 1 recruiting

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ming-Yuan Chen, MD,PhD, 86-20-8734-2422, chmingy@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Whole-target Consolidation Therapy After Standard Chemotherapy for Initial Diagnosed Distant Metastatic Nasopharyngeal Carcinoma Under Full-course Immunotherapy: An Open-Label, Single Center, Nonrandomized, Phase 2 Study

In this exploratory clinical trial, patients with newly diagnosed distant metastatic nasopharyngeal carcinoma were treated with gemcitabine+ cisplatin+PD-1 inhibitor regimen followed by whole-target radiotherapy (IMRT for local regional lesion, SBRT for distant metastasis) and PD-1 inhibitor long-term maintenance regimen. To investigate the efficacy and safety of "whole target" radiotherapy combined with immuno-maintenance therapy.

Read the detailed description

This exploratory clinical trial will evaluate tumor control rate, survival, and safety of newly diagnosed distant metastatic nasopharyngeal carcinoma by further adding local regional IMRT, distant metastatic SBRT and immuno-maintenance therapy to the standard regimen of gemcitabine+ cisplatin+ PD-1 inhibitor (historical data). To explore whether the "full target" model can be a better comprehensive therapy for the initial diagnosed distant metastatic nasopharyngeal carcinoma in the era of immunotherapy.

Being tested
Camrelizumab, gemcitabin, cisplatin, Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy
Keywords
Oligometastatic Nasopharyngeal Carcinoma, Immunotherapy, Stereotactic Body 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.

  • Camrelizumab, gemcitabin, cisplatinDrug

    Also called PD-1 inhibitor

    Patients receive gemcitabine (1000 mg/m² d1,8), cisplatin (80mg/m² d1), and camrelizumab (200mg, iv drip for over 60min) every 3 weeks for 6 cycles before locoregional radiotherapy.

  • Stereotactic Body Radiotherapy, Intensity modulated-radiotherapyRadiation

    Also called SBRT, IMRT

    IMRT: 5 fractions per week for 6 weeks to a total dose of 70 Gy and 33 fractions to the primary tumor.

    SBRT: 3 months after locoregional IMRT, patients receive SBRT for all oligometastatic lesions as radical therapy to control the disease and reduce any potential adverse impact to living quality. The dosage is based on published clinical studies.

    Camrelizumab (200mg, iv drip for over 60min) every 2 weeks began on the first day of IMRT 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 NCT05431764
Study groupRoleWhat they receive
Camrelizumab Plus Stereotactic Body RadiotherapyExperimentalPatients were treated with gemcitabine, cisplatin and camrelizumab for 6 cycles, followed by whole-target radiotherapy (IMRT for locoregional lesion and SBRT for oligometastatic lesions) and camrelizumab maintenance therapy.
Receives: Drug: Camrelizumab, gemcitabin, cisplatin; Radiation: Stereotactic Body Radiotherapy, Intensity modulated-radiotherapy

What is being measured

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

  1. Median progression-free survival (PFS)

    Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.

    Measured: 2 years

Secondary outcomes (7)

  1. Objective response rate (ORR)

    Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.

    Measured: 2 years

  2. Disease control rate (DCR)

    Disease control rate is the rate of patients achieving complete response, partial response or stable disease for at least 4 weeks after intervention.

    Measured: 2 years

  3. Median overall survival (OS)

    Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened

    Measured: 2 years

  4. Adverse events

    NCI-CTC5.0 and RTOG standards are adopted, and acute subjective toxicity, acute objective toxicity and late subjective toxicity are included.

    Measured: 2 years

  5. 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, and after treatment.

    Measured: 2 years

  6. 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: 2 years

  7. Duration of response (DoR)

    Defined as the time from first documentation of objective response to radiological disease progression.

    Measured: 2 years

Timeline

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

  1. First posted24 Jun 2022
  2. Study start20 Jun 2022 (estimated)
  3. Primary completion20 Jun 2025 (estimated)
  4. Study completion20 Jun 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431764
Sponsor's protocol ID
SYSUCC-SBRT2022
Status last verified
Jun 2022
First submitted
19 Jun 2022
Last updated
24 Jun 2022
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 2 study testing Camrelizumab, gemcitabin, cisplatin and Stereotactic Body Radiotherapy, 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 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: status not confirmed, as of the sponsor's last update on 24 Jun 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?

Contact Ming-Yuan Chen, MD, PhD (86-20-8734-3361, 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?

Median progression-free survival (PFS) (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 NCT05431764.

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 24 Jun 2022.

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