Nasopharyngeal Cancinoma (NPC)Phase 2NCT07067268
Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy
A Phase 2 study testing Adjuvant therapy in people with Nasopharyngeal Cancinoma (NPC), run by Fudan University at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Adjuvant therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2024to Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Histologically confirmed nasopharyngeal carcinoma;
- Expected survival time ≥12 weeks;
- ECOG performance status: 0-1;
- Received definitive radiotherapy (± induction and/or concurrent chemotherapy);
- Plasma EBV DNA >0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ;
- Adequate organ function meeting the following criteria: Hematological: a. Hemoglobin (HB) ≥90 g/L; b. Absolute neutrophil count (ANC) ≥1.0×10⁹/L; c. Platelet count (PLT) ≥80×10⁹/L; Biochemical: a. Total bilirubin (BIL) <1.5× upper limit of normal (ULN); b. ALT and AST <2.5×ULN; c. Serum creatinine (Cr) ≤ULN, and creatinine clearance rate ≥50 mL/min (calculated by Cockcroft-Gault formula); d. Normal myocardial enzymes and thyroid function; e. Normal cardiac function assessed by echocardiography.
- Signed informed consent with willingness to comply with the study protocol.
Who cannot join
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)；
- Distant metastasis detected by pre-treatment clinical or imaging examinations;
- History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;
- History of autoimmune diseases, except for the following conditions (eligible after evaluation):
- Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;
- Type I diabetes mellitus under stable insulin therapy with controlled blood glucose;
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- Previous or concurrent malignancies (except those cured and disease-free for >5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);
- Positive pregnancy test in women of childbearing potential;
- Concurrent medical conditions that may compromise patient enrollment or safety during the study;
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases;
- Active psychiatric disorders or other mental conditions affecting informed consent comprehension;
- Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+);
- Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular/ventricular arrhythmias requiring clinical intervention;
- Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric/neurological disorders, chronic diarrhea, ascites, pleural effusion);
- Unwillingness to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Universtiy Shanghai Cancer Centre
Shanghai, China, 200032
Hongmei Ying, M.D., +8602164175590 ext. 86703, yinghongmei2013@163.com
About this study
Official title: A Multicenter, Randomized Controlled, Phase II Trail of Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA After Radiotherapy
This study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Adjuvant therapy
- Keywords
- Nasopharyngeal Carcinoma, EBV DNA, Tislelizumab, capecitabine, Adjuvant therapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant therapyDrug
Tislelizumab: 200 mg IV on day 1, every 3 weeks Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks Treatment duration: 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant therapy arm | Experimental | Tislelizumab combined with capecitabine therapy Receives: Drug: Adjuvant therapy |
| Control arm | No intervention | Clinical follow-up and surveillance only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Defined from date of randomization to date of first documentation of progression or death due to any cause
Measured: 3 years
Secondary outcomes (2)
Overall survival
The time from enrollment to death due to any cause or censored at the date of last follow-up.
Measured: 3 years
Toxicities
Adverse effects (AE) are evaluated by CTCAE 4.0
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 posted16 Jul 2025
- Study start14 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2029 (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 Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067268
- Sponsor's protocol ID
- BioNPC-03
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled, Phase II Trail of Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA After Radiotherapy
- ClinicalTrials.gov ID
- NCT07067268
- Acronym / sponsor ID
- BioNPC-03
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma, EBV DNA, Tislelizumab, capecitabine, Adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Jul 2025 (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 study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant therapy arm | Experimental | Drug: Adjuvant therapyTislelizumab combined with capecitabine therapy |
| Control arm | No intervention | –Clinical follow-up and surveillance only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years;
- Histologically confirmed nasopharyngeal carcinoma;
- Expected survival time ≥12 weeks;
- ECOG performance status: 0-1;
- Received definitive radiotherapy (± induction and/or concurrent chemotherapy);
Key exclusion criteria (15 listed)
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)；
- Distant metastasis detected by pre-treatment clinical or imaging examinations;
- History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;
- History of autoimmune diseases, except for the following conditions (eligible after evaluation):
- Previous or concurrent malignancies (except those cured and disease-free for >5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);
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 |
|---|---|---|
| Adjuvant therapyTislelizumab: 200 mg IV on day 1, every 3 weeks Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks Treatment duration: 8 cycles | Drug | Adjuvant therapy arm |
Primary outcome
Progression-free survival
Time frame: 3 years
Defined from date of randomization to date of first documentation of progression or death due to any cause
2 secondary outcomes
Overall survival
Time frame: 3 years
Toxicities
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 16 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adjuvant therapy in people with Nasopharyngeal Cancinoma (NPC), run by Fudan 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 8 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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 Hongmei Ying (+8602164175590-86703, yinghongmei2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (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 16 Jul 2025.