Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma

August 9, 2026 updated by: Chaosu Hu, Fudan University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

148

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan Universtiy Shanghai Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low-risk group

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
Other: Observation
Clinical follow-up and surveillance only.
Experimental: Medium-risk group
Capecitabine for medium-risk group after IMRT
Drug: Adjuvant therapy
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles
Drug: Adjuvant therapy

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）
Experimental: High-risk group
Tislelizumab and Capecitabine for high-risk group after IMRT
Drug: Adjuvant therapy
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles
Drug: Adjuvant therapy

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）

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overal Survival，OS
Time Frame: 2 years
calculated from the date of diagnosis of NPC to the date of death from any cause
2 years
Locoregionally Failure Free Survival，LRFFS
Time Frame: 2 years
calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier.
2 years
Distant failure free survival, DFFS
Time Frame: 2 years
calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
2 years
Adverse effects (AE)
Time Frame: during and after treatment （up to 2 years）
during and after treatment （up to 2 years）
Objective Response Rate
Time Frame: at the end of, 3 months and 6 months after IMRT
at the end of, 3 months and 6 months after IMRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiayun He, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 9, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 9, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAPT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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