A Phase 2 interventional study of Sintilimab and ipilimumab in Nasopharyngeal Carcinoma (NPC) and Metastatic Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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Among 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University — 80 open to participants now, 107 under way, 43 of them phase 3. Nasopharyngeal Carcinoma · Sun Yat-sen University.
Among the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University, this one is the 148th largest by planned enrollment of the 161 interventional ones that give a count, is one of 14 that started in 2026, is one of 72 in phase 2, reaches primary completion later than 101 of the 106 other live ones, and was the 184th registered.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
Browse Nasopharyngeal Carcinoma studies →80 of the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University are open now, in 2 countries. Recruiting first, the newest first:
Sun Yat-sen University · Sites in China
Ages 18–70
Sun Yat-sen University · Sites in China
Ages 18–70
Sun Yat-sen University · Sites in China
Ages 2–18
Sun Yat-sen University · Sites in China
Ages 18–70
Sun Yat-sen University · Sites in China
Ages 18–70
By country, each count listing its studies:
Of the 186 Nasopharyngeal Carcinoma studies recruiting now, 42 (23%) set no upper age limit and 135 (73%) stop at 75 or younger; 9 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
186 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 81 · Phase 3 64
First in 1998; this study’s year is marked. 14 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 28 is below the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Median enrollment 162 across the 161 interventional studies, 470 across the 25 observational. Of the 28 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sun Yat-sen University is the lead sponsor of 1,691 studies on the registry; 619 are open to participants now.
21 of the studies in Nasopharyngeal Carcinoma by Sun Yat-sen University that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04436965Phase 3Sun Yat-sen UniversityEffect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition | 2026-12 |
| NCT05340491Phase 3Sun Yat-sen UniversityChemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial | 2026-12 |
| NCT03907826Phase 3Sun Yat-sen UniversityPD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients | 2026-12 |
| NCT06241612Phase 3Sun Yat-sen UniversityIndividualized Elective Neck Irradiation in NPC Patients | 2026-12-31 |
| NCT06239727Phase 3Sun Yat-sen UniversityReduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response | 2027-02-20 |
Add all 21 to your calendar (.ics) → With an account.
Among the 186 studies in Nasopharyngeal Carcinoma by Sun Yat-sen University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The RADIANCE trial plans to enroll patients with chemotherapy-ineligible de novo metastatic nasopharyngeal carcinoma (AJCC 9th edition, TxNxM1). Participants will receive Radscopal radiotherapy, consisting of low-dose radiotherapy to the primary lesions and stereotactic body radiotherapy to distant metastatic lesions, in combination with sintilimab and ipilimumab. The study will evaluate the objective response rate of the primary lesions, systemic disease control as measured by progression-free survival and overall survival, and the safety and tolerability of this treatment regimen.
The main questions this study aims to answer are:
Does this treatment improve efficacy with acceptable safety in chemotherapy-ineligible patients? Does Radscopal radiotherapy enhance systemic antitumor immunity, and what is the Radscopal Response Rate? What clinical and immunological factors are associated with the Radscopal effect, and what mechanisms may underlie this effect?
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive LDRT to the primary lesions, SBRT to selected metastatic lesions, and intravenous sintilimab and ipilimumab.
Drug: Sintilimab · Drug: ipilimumab · Radiation: Radscopal Radiotherapy
Sintilimab 200 mg will be administered by intravenous infusion once every 2 weeks, starting within 7 days after completion of stereotactic body radiotherapy, until unacceptable toxicity, disease progression, or for up to 6 months.
Also known as: PD-1 antibody, IBI308
Ipilimumab 1 mg/kg will be administered by intravenous infusion once every 6 weeks for 2 cycles, beginning on the same day as the first sintilimab infusion.
Also known as: CTLA-4 antibody, IBI310
Participants will receive low-dose radiotherapy to the primary tumors at 8 Gy in 8 fractions. Stereotactic body radiotherapy will also be delivered to distant metastatic lesions at 24 Gy in 3 fractions.
Also known as: LDRT combined with SBRT
Objective Response Rate (ORR) of Primary Lesions
The proportion of participants with confirmed complete response or partial response in measurable primary lesions (nasopharyngeal and neck), assessed according to RECIST version 1.1.
Time frame: 6 months
Objective Response Rate by Lesion Irradiation Type
The proportion of lesions achieving complete response or partial response among stereotactic body radiotherapy-treated, low-dose radiotherapy-treated, and non-irradiated lesions according to RECIST version 1.1.
Time frame: 6 months
Disease Control Rate (DCR)
The proportion of patients achieving complete response, partial response, or stable disease according to RECIST version 1.1.
Time frame: 6 months
Duration of Response (DoR)
The time from first documented complete response or partial response to disease progression or death from any cause.
Time frame: 1 year
One-Year Progression-Free Survival (PFS)
Calculated from enrollment to the date of disease progression or death from any cause, whichever occurred first.
Time frame: 1 year
One-Year Overall Survival (OS)
Calculated from enrollment to the date of death from any cause.
Time frame: 1 year
Adverse Events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE version 5.0.
Time frame: 1 year
Quality of Life (QoL): EORTC QLQ-C30
Change in QoL from baseline will be assessed using the EORTC QLQ-C30 questionnaire. The questionnaire includes functional scales, symptom scales, a global health status scale, and single-item symptom scales. Scores will be calculated according to the EORTC scoring manual.
Time frame: 1 year
Quality of Life (QoL): EORTC QLQ-HN35
Change in head and neck cancer-specific QoL from baseline will be assessed using the EORTC QLQ-HN35 questionnaire. Scores will be calculated according to the EORTC scoring manual.
Time frame: 1 year
Objective Response Rate (ORR) by Prespecified Subgroups
ORR will be summarized in prespecified subgroups defined by number of metastatic lesions, PD-L1 CPS level, metastatic pattern, and baseline plasma EBV DNA level.
Time frame: 6 months
Immune cell subsets of tissue samples
Relative abundance and activation status of immune cell subsets in tumor tissue will be assessed by single-cell RNA sequencing of fresh biopsy samples and compared between responders and non-responders.
Time frame: From baseline to tumor response assessment
Serum cytokine levels
Changes in Serum cytokine levels will be measured using a serum cytokine assay in serial peripheral blood samples to explore systemic immune response throughout the study.
Time frame: From baseline to the end of treatment
Plan to share: Yes — Complete de-identified patient data set underlying the results reported in the primary trial publication.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: For 2 years starting 12 months after publication of the primary trial report.
Access criteria: Authoritative researchers who provide a methodologically sound proposal for individual participant data meta-analysis.
Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.
Of 128 non-industry phase 2 interventional studies under Nasopharyngeal Carcinoma, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 74. This study's planned 39 months is below that.
Counting every sponsor, half of 143 studies reached it within 43 months; a quarter within 28 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sintilimab · Ipilimumab