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

NCT06676722 | Recruiting Phase 2 DMC

• 1 other identifier: 2023152
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Nasopharyngeal Cancinoma (NPC); SBRT; Immunotherapy

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• Progression-free survival rate

  6 months

Study Arms (1)

Experimental

EXPERIMENTAL

SBRT combined with Nimotuzumab followed by Tislelizumab

Drug: SBRT combined with Nimotuzumab followed by Tislelizumab

Interventions

SBRT combined with Nimotuzumab followed by Tislelizumab DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (2)

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

Central Study Contacts

San-Gang Wu, MD., PHD

CONTACT

865922139531; wusg@xmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)