Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT07154069

Adaptive Immunotherapy for Nasopharyngeal Carcinoma

Led by Sun Yat-sen University · Updated on 2025-11-25

802

Participants Needed

1

Research Sites

407 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy. 2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.

CONDITIONS

Official Title

Adaptive Immunotherapy for Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Newly diagnosed, pathologically confirmed non-keratinizing carcinoma
  • Locoregionally advanced nasopharyngeal carcinoma (Stage II-III) per AJCC 9th edition
  • ECOG performance status of 0 or 1
  • Adequate bone marrow function: WBC > 4 x 10^9/L, hemoglobin > 90 g/L, platelet count > 100 x 10^9/L
  • Normal kidney and liver function within specified limits
  • Normal thyroid, amylase, lipase, and pituitary function
  • Completion of 3 cycles of GP regimen induction chemotherapy combined with PD-1 inhibitor immunotherapy
  • Signed informed consent and ability to comply with study procedures
  • Female participants of childbearing potential must use reliable contraception from screening until one year after treatment
Not Eligible

You will not qualify if you...

  • T3N0-1 stage according to AJCC 9th edition
  • Disease progression after induction therapy
  • Positive hepatitis B surface antigen with high HBV DNA or positive hepatitis C antibody
  • Positive HIV antibody or diagnosis of AIDS
  • Active tuberculosis
  • Active, known, or suspected autoimmune disease except specified exceptions
  • History of interstitial lung disease or pneumonia requiring steroids in the past year
  • Chronic systemic glucocorticoid or other immunosuppressive therapy (inhaled or topical corticosteroids allowed)
  • Uncontrolled heart disease
  • Pregnant or breastfeeding women
  • History or current diagnosis of other cancers except certain treated skin, cervical, or thyroid cancers
  • Known allergy to toripalimab or its components
  • Active infection needing systemic treatment within one week prior to enrollment
  • Receipt of live vaccine within 30 days before starting toripalimab
  • History of organ transplantation
  • Contraindications to MRI preventing required imaging
  • Any condition that may compromise safety or compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

L

Ling-Long Tang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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