Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06277050

Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

Led by Jiangxi Provincial Cancer Hospital · Updated on 2024-04-30

264

Participants Needed

3

Research Sites

310 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure. The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).

CONDITIONS

Official Title

Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed nasopharyngeal carcinoma
  • High-risk nasopharyngeal cancer with one of the following: TanyN3M0; high-grade regional extranodal extension (rENE), coalescent nodal or invasion of surrounding structures; detectable EBV DNA after 2 cycles of induction chemotherapy
  • Age between 18 and 70 years, any gender
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Completed 2-3 cycles of induction chemotherapy and concurrent chemoradiotherapy with intensity-modulated radiotherapy
  • Adequate organ function without recent blood transfusion or growth factor support as defined by specific blood counts and liver and kidney function tests
  • Negative pregnancy test for women of childbearing potential
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Recurrent or distant metastatic nasopharyngeal carcinoma
  • History of other malignant tumors within the past 5 years except cured basal cell carcinoma or cervical carcinoma in situ
  • Prior radiotherapy or systemic anti-cancer therapy including investigational agents for nasopharyngeal carcinoma
  • Previous therapy with anti-PD-1 monoclonal antibodies
  • Active or relapsing autoimmune diseases
  • Use of systemic corticosteroids or immunosuppressive medication within 14 days before study start, except certain low-dose or topical steroids
  • History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases
  • Severe active infections requiring systemic therapy or recent severe infections
  • Known HIV infection
  • Untreated chronic hepatitis B or active hepatitis C infection
  • Major surgery requiring general anesthesia within 28 days before study start
  • Prior allogeneic stem cell or organ transplantation
  • Significant cardiovascular risk factors or recent cardiovascular events
  • History of severe hypersensitivity to toripalimab, capecitabine, or their components
  • Use of herbal medicine for cancer control within 14 days before study start
  • Unresolved toxicities from prior anticancer therapy except certain mild side effects
  • Participation in another therapeutic clinical study
  • Emotional disturbance or mental illness
  • Refusal or inability to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China, 341000

Not Yet Recruiting

2

First Affiliated hospital of Gannan Medical University

Guangzhou, Jiangxi, China, 341000

Actively Recruiting

3

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Nanchang, None Selected, China, 330029

Actively Recruiting

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Research Team

J

Jingao Li, MD

CONTACT

X

Xiaochang Gong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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