ClinicalTrials.gg
RecruitingNCT07177443Updated Sep 17, 2026

Serplulimab Combined With Induction Chemotherapy and Radiotherapy in Nasopharyngeal Carcinoma

A Phase 3 interventional study of Radiotherapy and Serplulimab in Locally Advanced Nasopharyngeal Carcinoma, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.

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Phase
Phase 3
Study type
Interventional
Enrollment
710
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 489 studies in Nasopharyngeal Carcinoma with a site in China — 203 open to participants now, 254 under way, 86 of them phase 3. Nasopharyngeal Carcinoma · China.

Planned enrollment
6th of 417
710 · median 126
Started
2025
with 39 others
Phase 3
121 of 489
61 open now
Primary completion
2035-12
later than 252 of 253 live
Registered
446th of 489
by date

Among the 489 studies in Nasopharyngeal Carcinoma with a site in China, this one is the 6th largest by planned enrollment of the 417 interventional ones that give a count, is one of 40 that started in 2025, is one of 121 in phase 3, reaches primary completion later than 252 of the 253 other live ones, and was the 446th registered.

Nasopharyngeal Carcinoma

683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.

Browse Nasopharyngeal Carcinoma studies →

Open to participants now

203 of the 489 studies in Nasopharyngeal Carcinoma with a site in China are open now. Recruiting first, the newest first:

198 more — sign in →

All 203 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

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 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 489 studies in Nasopharyngeal Carcinoma with a site in China, or all of them as a file.
02

Study summary

This phase III trial aims to evaluate the efficacy and safety of induction chemotherapy combined with serplulimab (induction/maintenance therapy) with omission of concurrent chemotherapy in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).

Read the detailed description

This multicenter phase III trial enrolls high-risk locally advanced nasopharyngeal carcinoma patients (AJCC 9th edition, Stage T1-3N2 [II] or T1-4N3/T4N1-2 [III]) who achieves ≥50% tumor regression (RECIST v1.1) and undetectable plasma EBV DNA after three cycles of GP induction chemotherapy (gemcitabine + cisplatin) combined with serplulimab. Eligible patients will be randomized to either:

Experimental arm: Radiotherapy alone followed by serplulimab maintenance, or Control arm: Cisplatin-based concurrent chemoradiotherapy (CCRT) followed by serplulimab maintenance.

Primary study endpoint

  • event-free survival (EFS) ② overall survival (OS) ③ Incidence of Hearing Loss (any grade) Secondary study endpoints
  • 3-year distant metastasis-free survival (DMFS)

    • 3-year locoregional recurrence-free survival (LRFS)

      • Quality of life (QoL) assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 v3.0) and its head-and-neck cancer module (EORTC QLQ-H\&N35 v1.0), both validated Chinese versions.

        • Incidence rate of investigator-reported adverse events (AEs)

          • Incidence rate of patient-reported AEs
03

Conditions studied

  • Locally Advanced Nasopharyngeal Carcinoma

Keywords

  • Cisplatin-based concurrent chemoradiotherapy
  • radiotherapy
  • Treatment De-escalation
  • locally advanced nasopharyngeal carcinoma
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Age at diagnosis: 18-65 years;
  2. confirmed treatment-naïve nasopharyngeal carcinoma of "non-keratinizing type (WHO classification)";
  3. Locoregionally advanced nasopharyngeal carcinoma staged per the 9th edition of the American Joint Committee on Cancer (AJCC) staging system: Stage II (T1-3N2), Stage III(T1-4N3 or T4N1-2);
  4. performance status: 0-1;
  5. Post-induction therapy requirements:

    Radiological assessment showing ≥50% tumor regression ( 1.1) Undetectable plasma EBV DNA levels;

  6. Adequate bone marrow function:

    White blood cell count >4×10⁹/L >90 g/L count >100×10⁹/L;

  7. Normal hepatic/renal function:

    Total ≤1.5× (ULN) /ALT ≤2.5×ULN Alkaline phosphatase ≤2.5×ULN ≥60 mL/min;

  8. Normal results for:

    Thyroid function tests Amylase and lipase Pituitary function Inflammatory/infection markers Cardiac enzymes

    Additional requirements:

    Pulmonary function tests for smokers >50 years Cardiac ultrasound + myocardial function tests for patients with ECG abnormalities or cardiovascular history (unless meeting exclusion criterion (8));

  9. Signed with willingness/compliance to follow study schedules for treatment, follow-up, and laboratory tests;
  10. For women of : Agreement to use reliable (e.g., condoms, prescribed oral contraceptives) from screening until 1 year post-treatment.

Exclusion criteria

Exclusion Criteria:

  1. Virus (HBV) Infection:

    HBsAg-positive with HBV DNA >1×10³ copies/mL (patients with controlled viremia [\<1×10³ copies/mL] after antiviral therapy are eligible).

  2. Virus (HCV) Infection: Anti-HCV antibody-positive.
  3. /AIDS: Anti-HIV antibody-positive or diagnosed with acquired immunodeficiency syndrome (AIDS).
  4. Active Tuberculosis (TB): History of active TB within the past year (regardless of treatment status). Exception: Patients with adequately treated past TB (confirmed by standard anti-TB therapy) may be enrolled if >1 year since completion of treatment.
  5. Active Diseases:Known or suspected autoimmune disorders (e.g., uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, or asthma requiring bronchodilators).

    Exceptions:

    Type 1 diabetes mellitus Hypothyroidism managed with hormone replacement Skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia).

  6. Interstitial Lung Disease (ILD):

    History of ILD or pneumonitis requiring oral/IV within the past year.

  7. Therapy:

    Chronic systemic corticosteroids (≥10 mg prednisone equivalent/day) or other immunosuppressants within 4 weeks prior to enrollment. Inhaled/topical steroids are permitted.

  8. Uncontrolled Cardiac Disease: Heart failure ( class ≥2), Unstable angina, Myocardial infarction within the past year, arrhythmias requiring treatment.
  9. Pregnancy/Lactation: Pregnant or breastfeeding women (urine/blood pregnancy test required for women of ).
  10. Concurrent :

    History of other malignancies except:

    Adequately treated non-melanoma skin cancer, Carcinoma in situ of the cervix, Papillary thyroid carcinoma.

  11. : Known allergy to any component of the study drugs or .
  12. Active Infections:

    Systemic infections requiring treatment within 1 week prior to enrollment.

    :

  13. Administration of live vaccines within 30 days before the first immunotherapy dose.
  14. Organ Transplantation: History of allogeneic organ transplantation.
  15. Other High-Risk Conditions:

Any condition that may compromise patient safety or compliance per investigator assessment (e.g., severe psychiatric disorders, life-threatening comorbidities, or social/familial risk factors).

Terms in these criteria, in plain language(25)

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.

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

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).

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.

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.

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.

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.

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.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

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.

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.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
710 participants (estimated)

Study arms

  • Experimental
    Experimental arm

    Radiotherapy

    Radiation: Radiotherapy · Drug: Serplulimab

  • Active comparator
    Control arm

    Cisplatin-based concurrent chemoradiotherapy (CCRT)

    Radiation: Radiotherapy · Drug: Serplulimab · Drug: Cisplatin

Interventions

  • RadiationRadiotherapy

    Following induction therapy, eligible patients will receive radiotherapy alone or concurrent chemoradiotherapy per protocol. Photon or proton radiotherapy techniques were permitted. Prescribed doses were: Primary tumor and metastatic lymph nodes: 70 Gy/33 fractions High-risk lymphatic drainage areas: 60 Gy/33 fractions Low-risk regions: 54 Gy/33 fractions PTV dose specifications: GTVnx: 70 Gy GTVnd: 66-70 Gy (reducible to 63 Gy for suspicious small nodes) CTV1: 60-62 Gy CTV2: 54-56 Gy All treatments will employ simultaneous integrated boost (SIB) intensity-modulated radiotherapy delivered once daily, 5 fractions per week.

  • Serplulimab will be used in the induction phase for 3 cycles and the maintenance phase for 14 cycles.

  • On days 64 and 85, patients will receive cisplatin chemotherapy at a dose of 100 mg/m² via intravenous infusion.

06

What researchers measure

Primary outcomes

  1. Event-free survival (EFS)

    EFS is defined as the time from the date of randomization to the first occurrence of disease recurrence (locoregional or distant) or death from any cause, whichever comes first.

    Time frame: 3-year

  2. Overall survival (OS)

    OS is defined as the time from the date of randomization until death from any cause.

    Time frame: 5-year

  3. Incidence of Hearing Loss (any grade)

    Proportion of participants experiencing any grade of hearing loss, assessed by pure-tone audiometry, auditory brainstem response, and acoustic immittance.

    Time frame: 3 years after radiotherapy

Secondary outcomes

  1. Distant metastasis-free survival (DMFS)

    Time from randomization to the first occurrence of distant metastasis or death from any cause.

    Time frame: 3-year

  2. Locoregional recurrence-free survival (LRFS)

    LRFS is defined as the time from the date of randomization to the first histologically or radiologically confirmed locoregional recurrence or death from any cause.

    Time frame: 3-year

  3. Health-Related Quality of Life assessed by EORTC QLQ-C30

    Changes in health-related quality of life from baseline (informed consent) until 60 months after radiotherapy completion, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), version 3.0. The QLQ-C30 includes functional scales (e.g., physical, role, emotional), global quality of life scale, and symptom scales (e.g., fatigue, pain, nausea/vomiting). Scores range from 0 to 100. For functional scales and global quality of life, a higher score represents a better level of functioning or well-being. For symptom scales, a higher score represents a greater severity of symptoms.

    Time frame: From baseline (at informed consent) up to 60 months after radiotherapy completion.

  4. Head and Neck Cancer-Specific Symptoms assessed by EORTC QLQ-H&N35

    Changes in head and neck cancer-specific symptoms and side effects from baseline (informed consent) until 60 months after radiotherapy completion, assessed using the EORTC Head and Neck Cancer Module (QLQ-H\&N35), version 1.0. The QLQ-H\&N35 assesses symptoms relevant to head and neck cancer patients (e.g., pain, swallowing, senses, speech, social eating). Scores range from 0 to 100. For all symptom scales, a higher score represents a greater severity of symptoms.

    Time frame: From baseline (informed consent) until 60 months after radiotherapy completion.

  5. Incidence rate of investigator-reported adverse events (AEs)

    Analysis of investigator-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0.

    Time frame: 3-year

  6. Incidence rate of patient-reported adverse events (AEs)

    Analysis of patient-reported adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by patients themselves

    Time frame: 3-year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2035, 123 months after the start.

Of 84 phase 3 interventional studies under Nasopharyngeal Carcinoma, half reached primary completion within 69 months of starting (the median), counting those still running; a quarter within 51 and three quarters within 82. This study's planned 123 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2025
First posted
Sep 17, 2025
StartActual
Sep 26, 2025
Primary completionEst.
Dec 31, 2035
CompletionEst.
Dec 31, 2035
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07177443
Responsible party
Sponsor
First posted
Sep 17, 2025
Start date
Sep 26, 2025
Primary completion
Dec 31, 2035 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Sep 17, 2026

Study contacts

Chao Wan
Contact
wanc@hust.edu.cn
+86 18062775069

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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