Nasopharyngeal Carcinoma (NPC)Phase 2NCT07762976
Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma
A Phase 2 study testing Observation and Adjuvant therapy in people with Nasopharyngeal Carcinoma (NPC), run by Fudan University at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Observation and 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
- 148 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Jul 2031
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 65 years old
- Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.
- AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.
- Baseline plasma EBV-DNA > 0, and able to complete dynamic monitoring according to the protocol.
- ECOG 0 - 1.
- Main organ functions meet the requirements: neutrophils ≥ 2.0×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL/min.
- Signed informed consent form, willing to complete the study according to the protocol.
Who cannot join
- Clinical or imaging examinations have confirmed distant metastasis.
- Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
- Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia).
- Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection.
- Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose > 10mg/day) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg/day or only uses inhaled or topical glucocorticoids, participation is allowed.
- Has a history of active tuberculosis (Mycobacterium tuberculosis infection) in the past year; if active tuberculosis has been fully treated and has been over one year ago, participation is allowed.
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- Has a history of interstitial lung disease.
- Has received live vaccines within 4 weeks before signing the informed consent form, or is about to receive live vaccines in the near future.
- Pregnant or lactating women, or reproductive-aged subjects who do not agree to take effective contraceptive measures.
- Has a history of other malignant tumors within the past 5 years, but the following situations are excluded: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc.
- Cannot take oral medications or have a known severe allergy to capecitabine, tislelizumab, or cisplatin/gemcitabine.
- Has any other conditions, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illness or family/social factors, which the investigator believes may affect the patient's ability to sign the informed consent form, cooperate and participate in the study, or interfere with the interpretation of the study results.
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 Center
Shanghai, Shanghai Municipality, 200032
Xiayun He, MD, +86021-64175590-81412, hexiayun1962@163.com
Fen Xue, MD, dr_fenxue@163.com
About this study
Official title: Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study
This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.
Read the detailed description
This study aims to evaluate whether the 2-year failure-free survival of NPC patients treated with GP induction chemotherapy, IMRT and risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy, is superior to that of a historical control cohort receiving standard treatment.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Observation, Adjuvant therapy
- Keywords
- Nasopharyngeal Carcinoma, EBV DNA, MRI, risk-adapted adjuvant therapy, Tislelizumab, capecitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Clinical follow-up and surveillance only.
Adjuvant therapyDrug
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles
Adjuvant therapyDrug
Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks.
Treatment duration: 8 cycles（Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles）
| Study group | Role | What they receive |
|---|---|---|
| Low-risk group | Other | Patient treated with induction chemotherapy（Gemcitabine 1000 mg/m², administered intravenously on days 1 and 8; Cisplatin 80 mg/m², administered intravenously on day 1 or in 3 divided doses; 1 cycle every 21 days, for a total of 2 cycles）, followed by IMRT. Then received risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy.
Clinical follow-up and surveillance only for low-risk group Receives: Other: Observation |
| Medium-risk group | Experimental | Capecitabine for medium-risk group after IMRT Receives: Drug: Adjuvant therapy |
| High-risk group | Experimental | Tislelizumab and Capecitabine for high-risk group after IMRT Receives: Drug: Adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Failure Free Survival, 2-y FFS
calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause，whichever comes earlier.
Measured: 2 years
Secondary outcomes (5)
Overal Survival，OS
calculated from the date of diagnosis of NPC to the date of death from any cause
Measured: 2 years
Locoregionally Failure Free Survival，LRFFS
calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier.
Measured: 2 years
Distant failure free survival, DFFS
calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
Measured: 2 years
Adverse effects (AE)
Measured: during and after treatment （up to 2 years）
Objective Response Rate
Measured: at the end of, 3 months and 6 months after IMRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
- Investigators
- Xiayun He, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762976
- Sponsor's protocol ID
- ADAPT-01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study
- ClinicalTrials.gov ID
- NCT07762976
- Acronym / sponsor ID
- ADAPT-01
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma, EBV DNA, MRI, risk-adapted adjuvant therapy, Tislelizumab, capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 13 Aug 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 study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.
Detailed description
This study aims to evaluate whether the 2-year failure-free survival of NPC patients treated with GP induction chemotherapy, IMRT and risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy, is superior to that of a historical control cohort receiving standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk group | Other | Other: ObservationPatient treated with induction chemotherapy（Gemcitabine 1000 mg/m², administered intravenously on days 1 and 8; Cisplatin 80 mg/m², administered intravenously on day 1 or in 3 divided doses; 1 cycle every 21 days, for a total of 2 cycles）, followed by IMRT. Then received risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy. Clinical follow-up and surveillance only for low-risk group |
| Medium-risk group | Experimental | Drug: Adjuvant therapyCapecitabine for medium-risk group after IMRT |
| High-risk group | Experimental | Drug: Adjuvant therapyTislelizumab and Capecitabine for high-risk group after IMRT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 - 65 years old
- Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.
- AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.
- Baseline plasma EBV-DNA > 0, and able to complete dynamic monitoring according to the protocol.
- ECOG 0 - 1.
Key exclusion criteria (12 listed)
- Clinical or imaging examinations have confirmed distant metastasis.
- Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies).
- Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia).
- Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection.
- Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose > 10mg/day) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg/day or only uses inhaled or topical glucocorticoids, participation is allowed.
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 |
|---|---|---|
| ObservationClinical follow-up and surveillance only. | Other | Low-risk group |
| Adjuvant therapyCapecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles | Drug | Medium-risk group |
| Adjuvant therapyTislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles（Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles） | Drug | High-risk group |
Primary outcome
2-year Failure Free Survival, 2-y FFS
Time frame: 2 years
calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause，whichever comes earlier.
5 secondary outcomes
Overal Survival，OS
Time frame: 2 years
Locoregionally Failure Free Survival，LRFFS
Time frame: 2 years
Distant failure free survival, DFFS
Time frame: 2 years
Adverse effects (AE)
Time frame: during and after treatment （up to 2 years）
Objective Response Rate
Time frame: at the end of, 3 months and 6 months after IMRT
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 13 Aug 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.
Xiayun He principal investigator
Fudan University
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 Observation and Adjuvant therapy in people with Nasopharyngeal Carcinoma (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 7 inclusion and 12 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 13 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 Xiayun He, MD (+86021-64175590-81412, hexiayun1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Failure Free Survival, 2-y FFS (time frame: 2 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 13 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.