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

March 14, 2024 updated by: Zhao Chong, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Cancer Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Recurrent or metastatic nasopharyngeal carcinoma patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chemoradiotherapy combined with immunotherapy
Patients treated with chemoradiotherapy combined with immunotherapy
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 target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).

Immunotherapy:PD-1 blocking antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ctDNA
Time Frame: through study completion, an average of 6 months
To show the changes of ctDNA during the treatment among these patients
through study completion, an average of 6 months
Tumor mutation load at DNA level
Time Frame: 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
through study completion, an average of 6 months
RNA expression
Time Frame: through study completion, an average of 6 months
To show the changes of RNA expression during the treatment among these patients
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Chong Zhao, M.D, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • multi-omics technique in NPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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