NCT07762976

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_2

Timeline
60mo left

Started Aug 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Jul 2031

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 5, 2026

Last Update Submit

August 9, 2026

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

Nasopharyngeal CarcinomaEBV DNAMRIrisk-adapted adjuvant therapyTislelizumabcapecitabine

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (5)

  • Overal Survival，OS

    2 years

  • Locoregionally Failure Free Survival，LRFFS

    2 years

  • Distant failure free survival, DFFS

    2 years

  • Adverse effects (AE)

    during and after treatment （up to 2 years）

  • Objective Response Rate

    at the end of, 3 months and 6 months after IMRT

Study Arms (3)

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

Other: Observation

Medium-risk group

EXPERIMENTAL

Capecitabine for medium-risk group after IMRT

Drug: Adjuvant therapy

High-risk group

EXPERIMENTAL

Tislelizumab and Capecitabine for high-risk group after IMRT

Drug: Adjuvant therapy

Interventions

ObservationOTHER

Clinical follow-up and surveillance only.

Low-risk group
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

Medium-risk group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

ObservationChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Xiayun He

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiayun He, MD

CONTACT

+86021-64175590-81412hexiayun1962@163.com

Fen Xue, MD

CONTACT

+8618916882304dr_fenxue@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2031

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)