Investigation of Multi-omics Technique to Predict the Efficacy of Chemoradiotherapy Combined With Immunotherapy for r/m NPC

Recruiting

• Conditions: Multi-omics Technique; Nasopharyngeal Carcinoma; Recurrent and Metastatic Nasopharyngeal Carcinoma; Efficacy of Chemoradiotherapy and Immunotherapy
• Interventions: Drug: cisplatin-based chemoradiotherapy combined with immunotherapy

• Registration Number: NCT06197776
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-26
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-09
• Study Start: 2024-07-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chemoradiotherapy combined with immunotherapy	cisplatin-based chemoradiotherapy combined with immunotherapy	Patients treated with chemoradiotherapy combined with immunotherapy

Primary Outcome Measures

Name	Time	Method
Failure-free survival	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 Outcome Measures

Name	Time	Method
ctDNA	through study completion, an average of 6 months	To show the changes of ctDNA during the treatment among these patients
Tumor mutation load at DNA level	through study completion, an average of 6 months	To show the changes of tumor mutation load at DNA level during the treatment among these patients
RNA expression	through study completion, an average of 6 months	To show the changes of RNA expression during the treatment among these patients

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China