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
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