New combo therapy aims to halt spread of nasopharyngeal cancer
NCT ID NCT04944914
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding a precise form of radiation (SBRT) to the immunotherapy drug camrelizumab helps control cancer better than camrelizumab alone in people with nasopharyngeal cancer that has spread to a few spots (oligometastatic). About 188 adults whose primary tumor is under control and who have had at least one round of chemotherapy will be randomly assigned to one of two groups. The main goal is to see how long patients live without their cancer getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab (an immunotherapy drug) and stereotactic body radiotherapy (SBRT, a precise type of radiation)
- What this could lead to
- If successful, this could show that adding targeted radiation to immunotherapy helps control cancer spread better than immunotherapy alone, potentially improving how long patients live without their cancer getting worse.
- What could go wrong
- This is a phase 3 trial, but it is still recruiting and results are not yet known. The combination may cause more side effects than immunotherapy alone, and it is only tested in a specific group of patients with limited metastases.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 188 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female; 18-70 years of age. 2. Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled. 3. Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect. 4. 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. 5. ECOG performance status of 0 or 1. 6. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT. 7. 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. 8. Maximum diameter of brain metastatic lesion no more than 3cm. 9. 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. 10. Life expectancy more than 12 weeks. Exclusion Criteria: 1. Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure. 2. CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency. 3. History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody. 4. chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy. 5. Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord. 6. Patient with brain metastasis who needs decompression surgery. 7. Other malignancy or malignant hydrothorax. 8. Concurrent known or suspicious autoimmune disease, including dementia and epilepsy. 9. Use of large dose corticosteroids within 4 weeks before study drug administration. 10. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. 11. Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening 12. 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. 13. 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. 14. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment. 15. Pregnancy or lactation. 16. Other ineligible patients according to attending doctor.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- Can a targeted drug outperform chemotherapy in Tough-to-Treat nasopharyngeal cancer?
- Can an experimental drug shrink advanced solid tumors?
- Can a targeted therapy replace harsh chemo in nasopharyngeal cancer?
- Could adding extra chemo before standard therapy beat nasopharyngeal cancer?
- Smart T-Cell engager aims to outsmart tumors in first human test