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NCT Number: NCT06197776

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

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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Key information

Conditions

Multi-omics Technique Carcinoma Disease Attributes Efficacy of Chemoradiotherapy and Immunotherapy Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Recurrence Recurrent and Metastatic Nasopharyngeal Carcinoma Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Chong Zhao, M.D

CONTACT

[email protected]

02087342638

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. ctDNA

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

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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing Miao, M.D

CONTACT

[email protected]

86-13631355201

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 9, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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