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

NCT06197776 | Recruiting DMC

• 1 other identifier: multi-omics technique in NPC
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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

  3 years

Secondary Outcomes (3)

• ctDNA

  through study completion, an average of 6 months

• Tumor mutation load at DNA level

  through study completion, an average of 6 months

• RNA expression

  through study completion, an average of 6 months

Study Arms (1)

chemoradiotherapy combined with immunotherapy

Patients treated with chemoradiotherapy combined with immunotherapy

Drug: cisplatin-based chemoradiotherapy combined with immunotherapy

Interventions

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

chemoradiotherapy combined with immunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recurrent or metastatic nasopharyngeal carcinoma patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Related Links

• Home Page of Cancer Center, Sun Yat-sen University

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Recurrence

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Chong Zhao, M.D

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingjing Miao, M.D

CONTACT

86-13631355201; miaojingjing90@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: January 9, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

CN (1)