Nasopharyngeal Cancinoma (NPC)Phase 3NCT07373990
Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma
A Phase 3 study testing tislelizumab, Gemcitabine + cisplatin (GP) and Cisplatin (100mg/m2) in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-sen University.
Trial summary
This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
- What is being tested?
- tislelizumab, Gemcitabine + cisplatin (GP) and Cisplatin (100mg/m2)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 31 Dec 2030
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤65 years
- Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
- Eastern Cooperative Oncology Group performance score of 0-1.
- Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition).
- Adequate marrow function:
- white blood cell count > 4 × 10⁹/L hemoglobin >90g/L and platelet count >100×10⁹/L
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- Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN, Alkaline phosphatase ≤ 2.5 ×ULN, clearance rate ≥ 60 ml/min 7. Other laboratory and clinical criteria Normal: thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG); For patients aged >50 years with a history of smoking, normal pulmonary function test (PFT) results are required; For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits.
- 8. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.
- 9. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug.
Who cannot join
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1×10 copies/mL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody
- Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
- Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment.
- Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
- History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
- Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone >10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.
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- Uncontrolled cardiac conditions, such as: Heart failure with New York Heart Association (NYHA) classi dication ≥ Class II; or Unstable angina; or History of myocardial infarction within the past year; or Supraventricular or ventricular arrhythmias requiring treatment or intervention
- Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)
- History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
- Known hypersensitivity to macromolecule protein products.
- Active infections requiring systemic treatment within 1 week prior to enrollment.
- Administration of live vaccines within 30 days prior to the first dose of tile.
- History of organ transplantation or hematopoietic stem cell transplantation.
- Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.
- Patients who have previously received immune checkpoint (CTLA-4, PD-1, PD-L1, etc.) inhibitor therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Short-course Tislelizumab Combined With Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized, Controlled, Multicenter, Phase 3 Non-inferiority Clinical Trial
This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.
- Being tested
- tislelizumab, Gemcitabine + cisplatin (GP), Cisplatin (100mg/m2), intensity-modulated radiotherapy
- Keywords
- tislelizumab, PD-1 antibody, short-course
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tislelizumabDrug
Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 3 cycles.
tislelizumabDrug
Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 5 cycles.
Gemcitabine + cisplatin (GP)Drug
neoadjuvent gemcitabine (1000 mg/m2 d1, d8) and cisplatin (80 mg/m2 d1) every 3 weeks for 3 cycles
Cisplatin (100mg/m2)Drug
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
intensity-modulated radiotherapyRadiation
Defnitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
| Study group | Role | What they receive |
|---|---|---|
| tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant) | Experimental | Patients will receive neoadjuvant gemcitabine (1000 mg/m2 d1, d8), cisplatin (80 mg/m2 d1) and tislelizumab (200 mg) every 3 weeks for 3 cycles, followed by defnitive intensitymodulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with tislelizumab (400 mg) every 6 weeks for 3 cycles. Receives: Drug: tislelizumab; Drug: Gemcitabine + cisplatin (GP); Drug: Cisplatin (100mg/m2); Radiation: intensity-modulated radiotherapy |
| tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant) | Active comparator | Patients will receive neoadjuvant gemcitabine (1000 mg/m2 d1, d8), cisplatin (80 mg/m2 d1) and tislelizumab (200 mg) every 3 weeks for 3 cycles, followed by defnitive intensitymodulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with tislelizumab (400 mg) every 6 weeks for 5 cycles. Receives: Drug: tislelizumab; Drug: Gemcitabine + cisplatin (GP); Drug: Cisplatin (100mg/m2); Radiation: intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free survival (FFS)
From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Measured: 3 years
Secondary outcomes (6)
Overall survival (OS)
From date of randomization until the date of death from any cause, whichever came first
Measured: 3 years
Distant metastasis-free survival (DMFS)
From date of randomization until the date of first documented distant metastasis, whichever occurred first
Measured: 3 years
Locoregional recurrence-free survival (LRRFS)
From date of randomization until the date of first documented locoregional recurrence, whichever occurred first
Measured: 3 years
Adverse events (AEs)
Graded according to CTCAE V5.0
Measured: within 5 years
Quality of life (QoL)
The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used.The change of QoL from randomization to 9 weeks (at the end of neoadjuvant treatment), 16 weeks (at the end of radiotherapy), 28 weeks (at the 3nd cycle of adjuvant tislelizumab treatment), 40 (at the 5nd cycle of adjuvant tislelizumab treatment, if available), 1 year, 2 years, 3 years, 4 years, and 5 years after randomization. This questionnaire comprises 30 questions, 24 aggregated into nine multi-question scales: five functioning scales (e.g., physical), three symptom scales (e.g., fatigue), and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual of EORTC QLQ-C30.
Measured: week 0, 9, 16, 28, 40 and 1 year, 2 years, 3 years, 4 years, and 5 years after randomization
cost-effectiveness analysis
Cost-effectiveness will be evaluated as the incremental cost per clinical outcome achieved (e.g., cost per quality-adjusted life year gained or cost per event avoided) when comparing the intervention and control groups.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373990
- Sponsor's protocol ID
- 2025-FXY-462-FLK
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Tislelizumab Combined With Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized, Controlled, Multicenter, Phase 3 Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT07373990
- Acronym / sponsor ID
- 2025-FXY-462-FLK
- Keywords
- tislelizumab, PD-1 antibody, short-course
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant) | Experimental | Drug: tislelizumab, Drug: Gemcitabine + cisplatin (GP), Drug: Cisplatin (100mg/m2), Radiation: intensity-modulated radiotherapyPatients will receive neoadjuvant gemcitabine (1000 mg/m2 d1, d8), cisplatin (80 mg/m2 d1) and tislelizumab (200 mg) every 3 weeks for 3 cycles, followed by defnitive intensitymodulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with tislelizumab (400 mg) every 6 weeks for 3 cycles. |
| tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant) | Active comparator | Drug: tislelizumab, Drug: Gemcitabine + cisplatin (GP), Drug: Cisplatin (100mg/m2), Radiation: intensity-modulated radiotherapyPatients will receive neoadjuvant gemcitabine (1000 mg/m2 d1, d8), cisplatin (80 mg/m2 d1) and tislelizumab (200 mg) every 3 weeks for 3 cycles, followed by defnitive intensitymodulated radiotherapy (IMRT) of 6996cGy in 33 fractions. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Subsequently, adjuvant therapy with tislelizumab (400 mg) every 6 weeks for 5 cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 and ≤65 years
- Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.
- Eastern Cooperative Oncology Group performance score of 0-1.
- Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition).
- Adequate marrow function:
Key exclusion criteria (15 listed)
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA >1×10 copies/mL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody
- Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).
- Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment.
- Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.
- History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tislelizumabNeoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 3 cycles. | Drug | tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant) |
| tislelizumabNeoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 5 cycles. | Drug | tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant) |
| Gemcitabine + cisplatin (GP)neoadjuvent gemcitabine (1000 mg/m2 d1, d8) and cisplatin (80 mg/m2 d1) every 3 weeks for 3 cycles | Drug | tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant), tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant) |
| Cisplatin (100mg/m2)Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation | Drug | tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant), tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant) |
| intensity-modulated radiotherapyDefnitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions. | Radiation | tislelizumab (3×200 mg q3w neoadjuvant + 3×400 mg q6w adjuvant), tislelizumab (3×200 mg q3w neoadjuvant + 5×400 mg q6w adjuvant) |
Primary outcome
Failure-free survival (FFS)
Time frame: 3 years
From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
6 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Distant metastasis-free survival (DMFS)
Time frame: 3 years
Locoregional recurrence-free survival (LRRFS)
Time frame: 3 years
Adverse events (AEs)
Time frame: within 5 years
Quality of life (QoL)
Time frame: week 0, 9, 16, 28, 40 and 1 year, 2 years, 3 years, 4 years, and 5 years after randomization
cost-effectiveness analysis
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tislelizumab, Gemcitabine + cisplatin (GP) and Cisplatin (100mg/m2) in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-sen University.
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 9 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jun Ma (+862087343469, majun2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free survival (FFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.