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Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

NCT05092217 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-10-25

No results posted yet for this study

Summary

Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Tirelizumab

Tirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.

PROCEDURE

salvage surgery

Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

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
2021-10-20
Primary Completion
2023-10-20
Completion
2024-10-20

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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 NCT05092217 on ClinicalTrials.gov