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

ConditionsMulti-omics TechniqueNasopharyngeal CarcinomaRecurrent and Metastatic Nasopharyngeal CarcinomaEfficacy of Chemoradiotherapy and Immunotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recurrent or metastatic nasopharyngeal carcinoma patients

All genders，range from 18～70 years old

ECOG score 0 ~ 1

Inform consent form

Disqualifiers

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;

Trial population

Recurrent or metastatic nasopharyngeal carcinoma patients

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • cisplatin-based chemoradiotherapy combined with immunotherapy

    Drug

    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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: chemoradiotherapy combined with immunotherapy1 intervention

Trial outcomes

Primary outcomes

1

Failure-free survival

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

Time frame
3 years

Secondary outcomes

1

ctDNA

To show the changes of ctDNA during the treatment among these patients

Time frame
through study completion, an average of 6 months
2

Tumor mutation load at DNA level

To show the changes of tumor mutation load at DNA level during the treatment among these patients

Time frame
through study completion, an average of 6 months
3

RNA expression

To show the changes of RNA expression during the treatment among these patients

Time frame
through study completion, an average of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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