Investigation of Multi-omics Technique to Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy for Recurrent and/or Metastatic Nasopharyngeal Carcinoma

Sun Yat-sen University1 site in 1 country50 target enrollmentJuly 15, 2024

ConditionsMulti-omics Technique Nasopharyngeal Carcinoma Recurrent and Metastatic Nasopharyngeal Carcinoma Efficacy of Chemoradiotherapy and Immunotherapy

Interventionscisplatin-based chemoradiotherapy combined with immunotherapy

Drugscisplatin-based chemoradiotherapy combined with immunotherapy

Overview

Phase: Not Applicable
Intervention: cisplatin-based chemoradiotherapy combined with immunotherapy
Conditions: Multi-omics Technique
Sponsor: Sun Yat-sen University
Enrollment: 50
Locations: 1
Primary Endpoint: Failure-free survival
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The observational clinical study will recruit 50 recurrent and/or metastatic nasopharyngeal carcinoma (r/mNPC) patients, to investigate the prediction values of multi-omics technique for the efficacy of chemoradiotherapy combined with immunotherapy.

Registry

clinicaltrials.gov

Start Date

July 15, 2024

End Date

December 30, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Zhao Chong

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Recurrent or metastatic nasopharyngeal carcinoma patients
•All genders，range from 18～70 years old
•ECOG score 0 \~ 1
•Inform consent form

Exclusion Criteria

•Have or are suffering from other malignant tumors;
•Participating in other clinical trials;
•Drug or alcohol addition;
•Do not have full capacity for civil acts;
•Mental disorder;
•Pregnancy or lactation;
•Severe complication, eg, uncontrolled hypertension.

Arms & Interventions

chemoradiotherapy combined with immunotherapy

Patients treated with chemoradiotherapy combined with immunotherapy

Intervention: cisplatin-based chemoradiotherapy combined with immunotherapy

Outcomes

Primary Outcomes

Failure-free survival

Time Frame: 3 years

To investigate the multi-omics technique to predict the 3-year failure-free survival of chemoradiotherapy combined with immunotherapy for r/m NPC patients

Secondary Outcomes

ctDNA(through study completion, an average of 6 months)
Tumor mutation load at DNA level(through study completion, an average of 6 months)
RNA expression(through study completion, an average of 6 months)