Nasopharyngeal Carcinoma Clinical Trials

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Dynamic Risk-adapted EBV-DNA and MRI-guided De-concurrent Chemotherapy in Nasopharyngeal Carcinoma: A Prospective Single-center Phase II Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age: 18 - 65 years old

• Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma.

• AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0.

• Baseline plasma EBV-DNA \> 0, and able to complete dynamic monitoring according to the protocol.

• ECOG 0 - 1.

• Main organ functions meet the requirements: neutrophils ≥ 2.0×10\^9/L, platelets ≥ 100×10\^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL/min.

• Signed informed consent form, willing to complete the study according to the protocol.

Locations
Other Locations
China
Fudan Universtiy Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xiayun He, MD
hexiayun1962@163.com
+86021-64175590-81412
Backup
Fen Xue, MD
dr_fenxue@163.com
+8618916882304
Time Frame
Start Date: 2026-08
Estimated Completion Date: 2031-07
Participants
Target number of participants: 148
Treatments
Other: Low-risk group
Patient treated with induction chemotherapy(Gemcitabine 1000 mg/m², administered intravenously on days 1 and 8; Cisplatin 80 mg/m², administered intravenously on day 1 or in 3 divided doses; 1 cycle every 21 days, for a total of 2 cycles), followed by IMRT. Then received risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy.~Clinical follow-up and surveillance only for low-risk group
Experimental: Medium-risk group
Capecitabine for medium-risk group after IMRT
Experimental: High-risk group
Tislelizumab and Capecitabine for high-risk group after IMRT
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov