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Clinical Trials/NCT06676722
NCT06676722RecruitingPhase 2

A Prospective, Single-Arm, Exploratory Study of SBRT Combined With Nimotuzumab and Sequential Tislelizumab for Oligoprogressive Distant Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of First-Line Immunotherapy

The First Affiliated Hospital of Xiamen University1 site in 1 country20 target enrollmentStarted: November 5, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Objective response rate (ORR)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 1.
  • 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.
  • Eligible to receive SBRT, Tislelizumab, and Nimotuzumab; 1.
  • No history of other malignant tumors; 1.
  • Male or female, aged 18-75 years; 1.
  • Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5 × ULN; 1.
  • Renal function: Creatinine clearance ≥ 80 mL/min; 1.
  • Hematological tests: Absolute neutrophil count (ANC) ≥ 2 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL; 1.
  • No severe dysfunction of heart, lung, and other vital organs; 1.
  • Performance Status (PS) score ≤

Exclusion Criteria

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

Arms & Interventions

Experimental

Experimental

SBRT combined with Nimotuzumab followed by Tislelizumab

Intervention: SBRT combined with Nimotuzumab followed by Tislelizumab (Drug)

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 6 months

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.

Secondary Outcomes

  • Progression-free survival rate(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

San-Gang Wu

Dr.

The First Affiliated Hospital of Xiamen University

Study Sites (1)

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