MedTrace Logo

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

NCT06277050 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-05-15

No results posted yet for this study

Summary

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

  • Nasopharyngeal Carcinoma
  • High-Risk Cancer
  • Maintenance Therapy

Interventions

DRUG

Maintenance Therapy with Toripalimab and Capecitabine

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months.

DRUG

Maintenance Therapy with Capecitabine

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months.

Sponsors & Collaborators

  • Jiangxi Provincial Cancer Hospital

    lead OTHER

Principal Investigators

  • Jingao Li · Jiangxi Provincial Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2030-02-20
Completion
2031-02-20

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06277050 on ClinicalTrials.gov