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Nasopharyngeal CarcinomaPhase 3NCT04944914

Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma

A Phase 3 study testing camrelizumab and stereotactic body radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site 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

We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter… 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 and stereotactic body radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteChina
Study dates
1 Jun 2021to 1 Jun 2028
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

  • Male or female; 18-70 years of age.
  • Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
  • Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
  • Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3.
  • ECOG performance status of 0 or 1.
  • Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
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  • If metastatic lesions have received local treatment (surgery, radiofrequency ablation, radiotherapy etc.):
  • Eligible if treated lesion is well controlled according to imageological examinations, and the lesion does not need stereotactic body radiotherapy.
  • If treated lesion is not controlled according to imageological examinations:
  • Eligible if the treatment is surgery and that stereotactic body radiotherapy is applicable for the treated lesion.
  • Ineligible if the treatment is radiofrequency ablation or radiotherapy.
  • 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 12 weeks.

Who cannot join

  • Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
  • CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
  • 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.
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  • Other malignancy or malignant hydrothorax.
  • Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.
  • 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. Contact the study team or a site near you to ask about taking part.

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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ming-Yuan Chen, MD, PhD, 86-20-8734-3624, chmingy@mail.sysu.edu.cn

    Ming-Yuan Chen, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma: A Multicenter Randomized Clinical Phase 3 Trial

We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter randomized phase 3 trial.

Read the detailed description

We intend to apply camrelizumab plus stereotactic body radiotherapy at oligometastatic lesions to patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical treatment through this multicenter randomized phase 3 trial to investigate whether stereotactic body radiotherapy at oligometastatic lesions on the basis of immunotherapy can achieve clinical cure among a part of patients with distant metastasis and improve their overall survival.

Being tested
camrelizumab, stereotactic body 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.

  • camrelizumabDrug

    Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy

  • stereotactic body radiotherapyRadiation

    Also called SBRT

    Patients receive stereotactic body radiotherapy 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.

Study groups in NCT04944914
Study groupRoleWhat they receive
Camrelizumab Plus Stereotactic Body RadiotherapyExperimentalPatients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy, and then receive stereotactic body radiotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
Receives: Drug: camrelizumab; Radiation: stereotactic body radiotherapy
CamrelizumabActive comparatorPatients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
Receives: Drug: camrelizumab

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. Clinical benefit rate (CBR)

    Clinical benefit rate is the rate of patients achieving complete response, partial response or stable disease for at least 6 months after intervention.

    Measured: 2 years

  4. 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

  5. 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 year

  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: 2 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: 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 posted30 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 2028 (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
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944914
Sponsor's protocol ID
SYSUCC-CMY-2021-
Status last verified
Jun 2025
First submitted
28 Jun 2021
Last updated
30 Apr 2026
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 camrelizumab and stereotactic body 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 15 inclusion and 16 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 30 Apr 2026. 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 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 (86-20-8734-3361, 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 NCT04944914.

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 30 Apr 2026.

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