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RecruitingNCT06676722Updated Jul 1, 2025

SBRT Combined With Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy

A Phase 2 interventional study of SBRT combined with Nimotuzumab followed by Tislelizumab in Nasopharyngeal Cancinoma (NPC), SBRT and Immunotherapy, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by The First Affiliated Hospital of Xiamen University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a single-arm, open-label, prospective, and exploratory investigation aimed at examining the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.

02

Conditions studied

  • Nasopharyngeal Cancinoma (NPC)
  • SBRT
  • Immunotherapy
03

In context

Lead sponsor

The First Affiliated Hospital of Xiamen University is the lead sponsor of 115 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

1.1. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 1.2. Patients with recurrent/metastatic nasopharyngeal carcinoma who have previously received first-line treatment including anti-PD-1 immune checkpoint inhibitor therapy and failed, presenting with oligoprogression (1-5 metastatic lesions); 1.3. Eligible to receive SBRT, Tislelizumab, and Nimotuzumab; 1.4. No history of other malignant tumors; 1.5. Male or female, aged 18-75 years; 1.6. Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5 × ULN; 1.7. Renal function: Creatinine clearance ≥ 80 mL/min; 1.8. Hematological tests: Absolute neutrophil count (ANC) ≥ 2 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL; 1.9. No severe dysfunction of heart, lung, and other vital organs; 1.10. Performance Status (PS) score ≤ 2.

Exclusion criteria

2.1. Disagree to sign the informed consent form; 2.2. Patients who cannot comply with regular follow-ups due to psychological, social, family, or geographical reasons; 2.3. Receiving other experimental treatments as part of a clinical study (during the treatment period of the clinical study); 2.4. Severe, uncontrolled infections or medical conditions; 2.5. Major organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy or immunotherapy; 2.6. Factors affecting drug administration, distribution, metabolism, or excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; 2.7. Overexposure to glucocorticoids within 2 weeks before immunotherapy; 2.8. Long-term use of immunosuppressive agents after organ transplantation.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Experimental

    SBRT combined with Nimotuzumab followed by Tislelizumab

    Drug: SBRT combined with Nimotuzumab followed by Tislelizumab

Interventions

  • DrugSBRT combined with Nimotuzumab followed by Tislelizumab

    BRT combined with 3 cycles of Nimotuzumab 400mg qw followed by maintain Tislelizumab for 2 years or until disease progression

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    To investigate the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.

    Time frame: 6 months

Secondary outcomes

  1. Progression-free survival rate

    The proportion of patients who are alive and free of disease relapse at 6 months after treatment.

    Time frame: 6 months

07

Study locations

2 of 2 sites recruiting
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian 361003, China
    Enrolling by invitation
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian 361003, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06676722
Lead sponsor
The First Affiliated Hospital of Xiamen University
Responsible party
San-Gang Wu (Dr., The First Affiliated Hospital of Xiamen University) — Principal investigator
First posted
Nov 6, 2024
Start date
Nov 5, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 1, 2025

Study contacts

San-Gang Wu, MD., PHD
Contact
wusg@xmu.edu.cn
865922139531

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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