Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06676722

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

Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-07-01

20

Participants Needed

2

Research Sites

164 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed non-keratinizing nasopharyngeal carcinoma
  • Recurrent or metastatic nasopharyngeal carcinoma with 1-5 progressing metastatic lesions after first-line anti-PD-1 immunotherapy failure
  • Eligible for SBRT, Tislelizumab, and Nimotuzumab treatment
  • No history of other malignant tumors
  • Male or female aged 18 to 75 years
  • Liver function with total bilirubin  upper limit of normal (ULN), AST and ALT  2.5 times ULN, alkaline phosphatase  5 times ULN
  • Renal function with creatinine clearance  80 mL/min
  • Hematological tests with absolute neutrophil count  2 x 10^9/L, platelet count  100 x 10^9/L, and hemoglobin  9 g/dL
  • No severe dysfunction of heart, lung, or other vital organs
  • Performance Status score  2
Not Eligible

You will not qualify if you...

  • Declining to sign the informed consent form
  • Inability to comply with regular follow-ups due to psychological, social, family, or geographical reasons
  • Receiving other experimental treatments during the clinical study
  • Severe, uncontrolled infections or medical conditions
  • Major organ dysfunction or decompensated heart, lung, kidney, or liver failure preventing radiotherapy or immunotherapy
  • Conditions affecting drug handling, such as mental or central nervous system abnormalities, chronic diarrhea, ascites, or pleural effusion
  • Recent overexposure to glucocorticoids within 2 weeks before immunotherapy
  • Long-term use of immunosuppressive agents following organ transplantation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361003

Enrolling by Invitation

2

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361003

Actively Recruiting

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Research Team

S

San-Gang Wu, MD., PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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