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Nasopharyngeal Carcinoma (NPC)Phase 2RADIANCENCT07756190

Radscopal Radiotherapy Plus Immunotherapy for Chemotherapy-Ineligible Patients With Newly Diagnosed Metastatic Nasopharyngeal Cancer: A Single-Center, Open-Label, Phase II Study

A Phase 2 study testing Sintilimab, ipilimumab and Radscopal Radiotherapy in people with Nasopharyngeal Carcinoma (NPC) and Metastatic Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Sintilimab, ipilimumab and Radscopal Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
1 Sep 2026to 30 Jun 2030
Phase
Phase 2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanping Mao, MD, PhD contact

+86 02087343545

maoyp@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Department of Radiation Oncology, SYSUCC, +86 02087343545, maoyp@sysucc.org.cn

Other trials in China

About this study

Official title: A Phase II Study of Radscopal Radiotherapy Combined With Immunotherapy as First-Line Treatment for Chemotherapy-Ineligible Patients With De Novo Metastatic Nasopharyngeal Carcinoma

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?

Being tested
Sintilimab, ipilimumab, Radscopal Radiotherapy
Keywords
Metastatic Nasopharyngeal Carcinoma, Immunotherapy, Radiotherapy, Combined Modality Therapy, Tumor Immunity
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Also called PD-1 antibody, IBI308

    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.

  • ipilimumabDrug

    Also called CTLA-4 antibody, IBI310

    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.

  • Radscopal RadiotherapyRadiation

    Also called LDRT combined with SBRT

    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.

Study groups in NCT07756190
Study groupRoleWhat they receive
Radscopal Radiotherapy Plus Sintilimab and IpilimumabExperimentalParticipants will receive LDRT to the primary lesions, SBRT to selected metastatic lesions, and intravenous sintilimab and ipilimumab.
Receives: Drug: Sintilimab; Drug: ipilimumab; Radiation: Radscopal Radiotherapy

What is being measured

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

  1. 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.

    Measured: 6 months

Secondary outcomes (8)

  1. 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.

    Measured: 6 months

  2. Disease Control Rate (DCR)

    The proportion of patients achieving complete response, partial response, or stable disease according to RECIST version 1.1.

    Measured: 6 months

  3. Duration of Response (DoR)

    The time from first documented complete response or partial response to disease progression or death from any cause.

    Measured: 1 year

  4. One-Year Progression-Free Survival (PFS)

    Calculated from enrollment to the date of disease progression or death from any cause, whichever occurred first.

    Measured: 1 year

  5. One-Year Overall Survival (OS)

    Calculated from enrollment to the date of death from any cause.

    Measured: 1 year

  6. Adverse Events (AEs) and serious adverse events (SAEs)

    Graded according to CTCAE version 5.0.

    Measured: 1 year

  7. 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.

    Measured: 1 year

  8. 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.

    Measured: 1 year

Timeline

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

  1. First posted10 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Dec 2029 (estimated)
  4. Study completion30 Jun 2030 (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
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07756190
Sponsor's protocol ID
SL-B2026-384-02
Acronym
RADIANCE
Status last verified
Jul 2026
First submitted
31 Jul 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Complete de-identified patient data set underlying the results reported in the primary trial publication.

Publications

  • Huang J, Theelen WSME, Belcaid Z, Najjar M, van der Geest D, Singh D, Cherry C, Balan A, White JR, Wehr J, Karchin R, Niknafs N, van den Heuvel MM, Velculescu VE, Smith KN, Baas P, Anagnostou V. Combination of pembrolizumab and radiotherapy induces systemic antitumor immune responses in immunologically cold non-small cell lung cancer. Nat Cancer. 2025 Oct;6(10):1676-1692. doi: 10.1038/s43018-025-01018-w. Epub 2025 Jul 22.

    PubMed 40696153

  • Zhou X, Zhou L, Yao Z, Huang M, Gong Y, Zou B, Zhu J, Liu Y, Peng F, Zhang Y, Yu M, Li Y, Na F, Wu Y, Kang K, Xiu W, Zhang X, Zhou L, Xu Y, Wang J, Wang Y, Yang X, Wu Y, Li R, Zhang Y, Yang Z, Zhou Z, Bai J, Yi X, Tong R, Yin L, Chen C, Niedermann G, Lu Y, Xue J. Safety and Tolerability of Low-Dose Radiation and Stereotactic Body Radiotherapy + Sintilimab for Treatment-Naive Stage IV PD-L1+ Non-Small Cell Lung Cancer Patients. Clin Cancer Res. 2023 Oct 13;29(20):4098-4108. doi: 10.1158/1078-0432.CCR-23-0315.

    PubMed 37581611

  • Zhang Z, Liu X, Chen D, Yu J. Radiotherapy combined with immunotherapy: the dawn of cancer treatment. Signal Transduct Target Ther. 2022 Jul 29;7(1):258. doi: 10.1038/s41392-022-01102-y.

    PubMed 35906199

  • Ngwa W, Irabor OC, Schoenfeld JD, Hesser J, Demaria S, Formenti SC. Using immunotherapy to boost the abscopal effect. Nat Rev Cancer. 2018 May;18(5):313-322. doi: 10.1038/nrc.2018.6. Epub 2018 Feb 16.

    PubMed 29449659

  • Darragh LB, Knitz MM, Hu J, Clambey ET, Backus J, Dumit A, Samedi V, Bubak A, Greene C, Waxweiler T, Mehrotra S, Bhatia S, Gadwa J, Bickett T, Piper M, Fakhoury K, Liu A, Petit J, Bowles D, Thaker A, Atiyeh K, Goddard J, Hoyer R, Van Bokhoven A, Jordan K, Jimeno A, D'Alessandro A, Raben D, McDermott JD, Karam SD. A phase I/Ib trial and biological correlate analysis of neoadjuvant SBRT with single-dose durvalumab in HPV-unrelated locally advanced HNSCC. Nat Cancer. 2022 Nov;3(11):1300-1317. doi: 10.1038/s43018-022-00450-6. Epub 2022 Nov 25.

    PubMed 36434392

  • Lim DW, Kao HF, Suteja L, Li CH, Quah HS, Tan DS, Tan SH, Tan EH, Tan WL, Lee JN, Wee FY, Jain A, Goh BC, Chua MLK, Liao BC, Ng QS, Hong RL, Ang MK, Yeong JP, Iyer NG. Clinical efficacy and biomarker analysis of dual PD-1/CTLA-4 blockade in recurrent/metastatic EBV-associated nasopharyngeal carcinoma. Nat Commun. 2023 May 15;14(1):2781. doi: 10.1038/s41467-023-38407-7.

    PubMed 37188668

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab, ipilimumab and Radscopal Radiotherapy in people with Nasopharyngeal Carcinoma (NPC) and Metastatic 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 11 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: opening soon, as of the sponsor's last update on 10 Aug 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 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?

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 Yanping Mao, MD, PhD (+86 02087343545, maoyp@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) of Primary Lesions (time frame: 6 months). 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 NCT07756190, which also lists 6 linked publications.

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 10 Aug 2026.

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