Nasopharangeal CancerPhase 2NCT07392320
A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma
A Phase 2 study testing TP+PD1+CCRT, PD-1 Monoclonal Antibody and Capecitabine in people with Nasopharangeal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharangeal Cancer
- What is being tested?
- TP+PD1+CCRT, PD-1 Monoclonal Antibody and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 10 Feb 2033
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and written informed consent must be signed.
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml.
- Efficacy after 3 cycles of induction immunochemotherapy assessed as complete response (CR) or partial response (PR) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
- ECOG performance status score of 0 or 1.
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- Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010^9/L, and Platele (PLT) ≥10010^9/L.
- Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 *ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).
Who cannot join
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Patients who have previously received radiotherapy or systemic chemotherapy.
- Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
- HIV positive.
- History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
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- Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
- Patients with immunodeficiency diseases or a history of organ transplantation.
- History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks.
- Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
- Patients with severe, uncontrolled medical conditions or infections.
- Concurrent use of other investigational drugs or participation in another clinical trial.
- Refusal or inability to sign the informed consent form for trial participation.
- Patients with other contraindications to the treatment.
- Patients with personality or psychiatric disorders, or those lacking or with limited legal capacity.
- Patients who are hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus DNA (HBV DNA) ≥ 1000 copies/ml. Patients who are HBsAg positive but have HBV DNA < 1000 copies/ml are eligible if the investigator determines that their chronic hepatitis B is stable and does not pose an increased risk.
- Patients with a positive HCV antibody test result, unless the polymerase chain reaction (PCR) test for HCV RNA is negative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qi Yang contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Pei-Yu Huang, +86-20-87343379, huangpy@sysucc.org.cn
About this study
Official title: A Randomized, Open-Label, Phase II Clinical Study Comparing Immunotherapy Combined With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy Maintenance Versus Capecitabine Maintenance in Locally Advanced High-Risk Nasopharyngeal Carcinoma
In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.
Read the detailed description
For high-risk locally advanced nasopharyngeal carcinoma, it remains essential to explore more effective treatment strategies and regimens. In the era of immunotherapy, the introduction of PD-1 monoclonal antibodies has provided significant survival benefits to patients with locally advanced nasopharyngeal carcinoma. However, different modes of intervention still warrant further exploration, and additional clinical evidence is needed for validation.
In this study, the investigators designed a randomized, open-label, phase II clinical trial focusing on high-risk locally advanced nasopharyngeal carcinoma (defined as T4 or N3 or EBV DNA ≥1500 copies/ml according to AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares the sequential approach of TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus maintenance therapy with capecitabine. The study aims to provide high-quality clinical evidence to optimize treatment strategies for high-risk locally advanced nasopharyngeal carcinoma.
- Conditions
- Nasopharangeal Cancer
- Being tested
- TP+PD1+CCRT, PD-1 Monoclonal Antibody, Capecitabine
- Keywords
- high-risk locally advanced nasopharyngeal carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP+PD1+CCRTDrug
Induction Chemoimmunotherapy (3 cycles, Q3W):
Induction chemotherapy consisted of three cycles of docetaxel (75 mg/m², day 1), cisplatin (75 mg/m², day 1), and penpulimab (200 mg, day 1), administered every 3 weeks.
Concurrent Chemotherapy (3 weeks post-induction, 2 cycles, Q3W):
concurrent cisplatin 100mg/m2 every 21days for two cycles during Intensity modulated-radiotherapy (IMRT)
PD-1 Monoclonal AntibodyDrug
Penpulimab 200 mg every 3 weeks for 8 cycles
CapecitabineDrug
Capecitabine 1000 mg/m² BID, days 1-14, for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant immunotherapy arm | Experimental | Adjuvant PD-1 monoclonal antibody maintenance Receives: Drug: TP+PD1+CCRT; Drug: PD-1 Monoclonal Antibody |
| Adjuvant chemotherapy arm | Experimental | Adjuvant capecitabine maintenance Receives: Drug: TP+PD1+CCRT; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival is calculated from the date of randomization to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Measured: 3 years
Secondary outcomes (5)
Overall survival
Overall survival is calculated from the date of randomization to death from any cause.
Measured: 3 years
Locoregional recurrence-free survival
Locoregional recurrence-free survival is calculated from the date of randomization to the date of documented locoregional recurrence or death from any cause.
Measured: 3 years
Distant metastasis-free survival
Distant metastasis-free survival is calculated from the date of randomization to the date of documented distant metastasis or death from any cause.
Measured: 3 years
Incidence of acute toxicity as assessed by CTCAE v5.0
Acute adverse events (those that occurred within 1 year of randomisation) are graded according to the Common Terminology Criteria for Adverse Events (version 5.0).
Measured: 3 years
Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group
Late adverse events (those occurring >1 year after randomisation) are graded according to the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group.
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 posted6 Feb 2026
- Study start10 Feb 2026
- Primary completion10 Feb 2031 (estimated)
- Study completion10 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharangeal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Yu Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392320
- Sponsor's protocol ID
- 2025-FXY-476
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2026
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase II Clinical Study Comparing Immunotherapy Combined With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy Maintenance Versus Capecitabine Maintenance in Locally Advanced High-Risk Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07392320
- Acronym / sponsor ID
- 2025-FXY-476
- Conditions
- Nasopharangeal Cancer
- Keywords
- high-risk locally advanced nasopharyngeal carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Feb 2031 (estimated)
- Study completion
- 10 Feb 2033 (estimated)
- First posted
- 6 Feb 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.
In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.
Detailed description
For high-risk locally advanced nasopharyngeal carcinoma, it remains essential to explore more effective treatment strategies and regimens. In the era of immunotherapy, the introduction of PD-1 monoclonal antibodies has provided significant survival benefits to patients with locally advanced nasopharyngeal carcinoma. However, different modes of intervention still warrant further exploration, and additional clinical evidence is needed for validation.
In this study, the investigators designed a randomized, open-label, phase II clinical trial focusing on high-risk locally advanced nasopharyngeal carcinoma (defined as T4 or N3 or EBV DNA ≥1500 copies/ml according to AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares the sequential approach of TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus maintenance therapy with capecitabine. The study aims to provide high-quality clinical evidence to optimize treatment strategies for high-risk locally 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 |
|---|---|---|
| Adjuvant immunotherapy arm | Experimental | Drug: TP+PD1+CCRT, Drug: PD-1 Monoclonal AntibodyAdjuvant PD-1 monoclonal antibody maintenance |
| Adjuvant chemotherapy arm | Experimental | Drug: TP+PD1+CCRT, Drug: CapecitabineAdjuvant capecitabine maintenance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation and written informed consent must be signed.
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage III disease (AJCC 9th edition staging) or pre-treatment plasma Epstein-Barr virus DNA (EBV DNA) ≥ 1500 copies/ml.
- Efficacy after 3 cycles of induction immunochemotherapy assessed as complete response (CR) or partial response (PR) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
Key exclusion criteria (18 listed)
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Patients who have previously received radiotherapy or systemic chemotherapy.
- Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
- HIV positive.
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 |
|---|---|---|
| TP+PD1+CCRTInduction Chemoimmunotherapy (3 cycles, Q3W): Induction chemotherapy consisted of three cycles of docetaxel (75 mg/m², day 1), cisplatin (75 mg/m², day 1), and penpulimab (200 mg, day 1), administered every 3 weeks. Concurrent Chemotherapy (3 weeks post-induction, 2 cycles, Q3W): concurrent cisplatin 100mg/m2 every 21days for two cycles during Intensity modulated-radiotherapy (IMRT) | Drug | Adjuvant chemotherapy arm, Adjuvant immunotherapy arm |
| PD-1 Monoclonal AntibodyPenpulimab 200 mg every 3 weeks for 8 cycles | Drug | Adjuvant immunotherapy arm |
| CapecitabineCapecitabine 1000 mg/m² BID, days 1-14, for 8 cycles. | Drug | Adjuvant chemotherapy arm |
Primary outcome
Progression-free survival
Time frame: 3 years
Progression-free survival is calculated from the date of randomization to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
5 secondary outcomes
Overall survival
Time frame: 3 years
Locoregional recurrence-free survival
Time frame: 3 years
Distant metastasis-free survival
Time frame: 3 years
Incidence of acute toxicity as assessed by CTCAE v5.0
Time frame: 3 years
Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group
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 24 Apr 2026.
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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.
Qi Yang contact
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 TP+PD1+CCRT, PD-1 Monoclonal Antibody and Capecitabine in people with Nasopharangeal Cancer, 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 10 inclusion and 18 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 24 Apr 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 Pei-Yu Huang (+86-20-87343379, huangpy@sysucc.org.cn), 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 24 Apr 2026.