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Recruiting NCT06197776

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

— Observational Multi-omics Technique Nasopharyngeal Carcinoma Recurrent and Metastatic Nasopharyngeal Carcinoma Efficacy of Chemoradiotherapy and Immunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cisplatin-based chemoradiotherapy combined with immunotherapy.
Who it may be relevant to
Registry conditions: Multi-omics Technique, Nasopharyngeal Carcinoma, Recurrent and Metastatic Nasopharyngeal Carcinoma, Efficacy of Chemoradiotherapy and Immunotherapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug cisplatin-based chemoradiotherapy combined with immunotherapy
    Chemotherapy:cisplatin-based chemotherapy GP/TP/PF/TPF Choice of chemotherapy regimen is decided by patient's doctor in charge. Radiation: Intensity Modulated Radiation Therapy All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning t

Primary outcome measures

  • Failure-free survival [Time frame: 3 years]
Secondary outcome measures (3)
  • ctDNA [Time frame: through study completion, an average of 6 months]
  • Tumor mutation load at DNA level [Time frame: through study completion, an average of 6 months]
  • RNA expression [Time frame: through study completion, an average of 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Cancer Center, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06197776 · multi-omics technique in NPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗