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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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chemoradiotherapy combined with immunotherapy

Patients treated with chemoradiotherapy combined with immunotherapy

cisplatin-based chemoradiotherapy combined with immunotherapy

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No