RecruitingNCT06197776

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

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


Sponsor

Sun Yat-sen University

Enrollment

50 participants

Start Date

Jul 15, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • Recurrent or metastatic nasopharyngeal carcinoma patients
  • All genders,range from 18~70 years old
  • ECOG score 0 \~ 1
  • Inform consent form

Exclusion Criteria7

  • 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.

Interventions

DRUGcisplatin-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


Locations(1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06197776


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