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
San-Gang Wu
Dr.
The First Affiliated Hospital of Xiamen University
Study Sites (1)
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