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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFudan University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Observation
  • Adjuvant therapy
  • Adjuvant therapy

Treatment groups

148 Participants
are divided into 3 treatment groups

Sponsors and collaborators