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Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma

NCT06680115 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-11-08

No results posted yet for this study

Summary

To evaluate the efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Secondary endpoints included 2-year overall survival (OS), distant failure-free survival (DFFS), locoregional failure-free survival (LRFFS), and adverse events.

Conditions

  • Nasopharyngeal Carcinoma (NPC)

Interventions

DRUG

Sintilimab

Induction chemotherapy stage: Sintilimab combined with GP regimen chemotherapy; Adjuvant chemotherapy stage: Sintilimab combined with Capecitabine

Sponsors & Collaborators

  • First Affiliated Hospital of Guangxi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2026-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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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 NCT06680115 on ClinicalTrials.gov