Can a Two-Pronged radiation strategy boost immunotherapy against advanced nasopharyngeal cancer?
NCT ID NCT07756190
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial is testing whether a special type of radiation called radscopal radiotherapy—which combines low-dose radiation to the main tumor and precise high-dose radiation to distant metastases—can enhance the effects of two immunotherapy drugs (sintilimab and ipilimumab) in people with metastatic nasopharyngeal carcinoma who cannot receive chemotherapy. The study aims to see if this combination can shrink tumors, control the disease throughout the body, and improve survival, while also being safe and tolerable. Participants will receive the treatment for up to six months, and researchers will monitor their response and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radscopal radiotherapy (low-dose radiotherapy to primary lesions plus stereotactic body radiotherapy to metastases) combined with sintilimab and ipilimumab
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for people with metastatic nasopharyngeal carcinoma who cannot receive chemotherapy, potentially improving tumor control and survival.
- What could go wrong
- This is a small phase II trial, so results may not be definitive. The combination may cause significant immune-related side effects, and the benefit over existing treatments is not yet established.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
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 80 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\. Age 18-80 years. * 2\. Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma (TxNxM1 according to AJCC 9th edition), with ≤10 measurable metastatic lesions. * 3\. At least one measurable nasopharyngeal lesion suitable for low-dose radiotherapy and at least one distant metastatic lesion suitable for stereotactic body radiotherapy. * 4\. ECOG performance status 0-2. * 5\. PD-L1 combined positive score (CPS) ≥1. * 6\. Chemotherapy-ineligible, including patients medically unsuitable for platinum-based chemotherapy or patients who refuse standard platinum-based chemotherapy after being fully informed. * 7\. Life expectancy ≥6 months. * 8\. Adequate organ function, including ANC ≥1.0 × 10\^9/L, platelets ≥75 × 10\^9/L, hemoglobin ≥80 g/L, ALT/AST ≤3 × ULN, bilirubin ≤2 × ULN, creatinine clearance ≥30 mL/min, and LVEF ≥45% or normal echocardiography. * 9\. No major surgery within 1 month before enrollment. * 10\. No immunosuppressive or immunomodulatory therapy within 1 month before immune checkpoint inhibitor treatment. * 11\. Written informed consent and ability to comply with study procedures and follow-up. Exclusion Criteria: * 1\. Age \<18 years. * 2\. \>10 metastatic lesions, meningeal metastasis, spinal cord compression, or lesions unsuitable for safe stereotactic body radiotherapy. * 3\. Other malignancy within 5 years, except cured basal cell carcinoma, squamous cell carcinoma of the skin, papillary thyroid carcinoma, or cervical carcinoma in situ. * 4\. Prior systemic immune checkpoint inhibitor therapy or prior nasopharyngeal radiotherapy. * 5\. Active hepatitis B infection, defined as HBsAg positivity with HBV DNA \>200 IU/mL or \>1000 copies/mL. * 6\. Positive hepatitis C virus antibody. * 7\. Active, known, or suspected autoimmune disease, except type 1 diabetes, hypothyroidism requiring only hormone replacement, or skin disorders not requiring systemic treatment. * 8\. Systemic corticosteroids equivalent to \>10 mg prednisone daily or other immunosuppressive therapy within 28 days before informed consent, except low-dose, inhaled, or topical corticosteroids. * 9\. Active tuberculosis, active tuberculosis within the previous year, or prior active tuberculosis without documented adequate anti-tuberculosis treatment. * 10\. History of interstitial lung disease. * 11\. Uncontrolled diabetes mellitus (fasting blood glucose \>13.9 mmol/L). * 12\. Live vaccine within 30 days before informed consent or planned live vaccination. * 13\. Known allergy to macromolecular protein preparations or to any component of sintilimab or ipilimumab. * 14\. HIV infection. * 15\. Any condition that may affect participant safety or compliance, including uncontrolled cardiovascular disease, active infection requiring systemic treatment, psychiatric illness, severe cognitive impairment, suicidal tendency, or relevant psychological, family, or social factors.
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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
Guangzhou, Guangdong, 510060, China
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- Can a lower radiation dose still beat nasopharyngeal cancer?