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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06197776
• Other study ID #: multi-omics technique in NPC
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Jingjing Miao, M.D
• Phone: 86-13631355201
• Email: miaojingjing90[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrent and Metastatic Nasopharyngeal Carcinoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ctDNA	To show the changes of ctDNA during the treatment among these patients	through study completion, an average of 6 months
Secondary	Tumor mutation load at DNA level	To show the changes of tumor mutation load at DNA level during the treatment among these patients	through study completion, an average of 6 months
Secondary	RNA expression	To show the changes of RNA expression during the treatment among these patients	through study completion, an average of 6 months

External Links

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