NCT06259721

Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

Efficacy and Safety of Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma: A Single-arm, Open-label, Multi-center Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Jiangxi Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.

Detailed description

Currently, there is still no uniform treatment regimen for treating recurrent or metastatic nasopharyngeal carcinoma patients who failed to first-line platinum-based chemotherapy. Anti-PD-1 monoclonal antibody showed efficacy and safety in previous studies, however, the efficacy of immunotherapy alone was limited. Immunotherapy combined with other treatment regimens for recurrent or metastatic nasopharyngeal carcinoma is a strategy that needs to be urgently explored. Epidermal growth factor receptor (EGFR) is an important target in the treatment of nasopharyngeal carcinoma. Nimotuzumab, an EGRF antibody selectively inhibits epidermal growth factor receptors, has shown strong clinical utility in Nasopharyngeal Carcinoma. Nimotuzumab is an IgG1 monoclonal antibody targeting EGFR. It can not only effectively block the EGFR signaling pathway to promote cell death, but also activate immunity through ADCC to mediate anti-tumor effects. Anti-PD-1 antibodies relieve inhibition of cytotoxic lymphocytes to promote tumor regression. Nimotuzumab targeting EGFR mediates antibody-dependent cellular cytotoxicity and promotes communication between immune cells, including natural killer and dendritic cells. This communication can trigger tumor antigen-specific cellular immunity and generate antigen-specific T lymphocyte responses. Furthermore, therefore, recruitment of adaptive and innate immunity and antibody-dependent cellular cytotoxicity may induce antitumor synergy. Considering that anti-PD1 monoclonal antibodies and nimotuzumab play a synergistic role in enhancing anti-tumor immunity. The combination of anti-EGFR monoclonal antibody and anti-PD-1 monoclonal antibody has shown good efficacy in recurrent and metastatic head and neck squamous cell carcinoma. The overall response rate (ORR) of the combination treatment reached 45%, better than the ORR of the anti-PD-1 monoclonal antibody alone (20%). As a new type of fluorouracil oral anticancer drug, capecitabine has better efficacy and lower toxicity than 5-Fu \[14\]. Two recent clinical trials have confirmed that maintenance therapy with capecitabine oral chemotherapy can effectively reduce the risk of metastasis in locally advanced nasopharyngeal carcinoma, suggesting that new fluorouracil drugs have good anti-cancer effects. Clinical studies from recurrent metastatic nasopharyngeal carcinoma also confirmed that capecitabine metronomic therapy can improve overall survival. Maintenance chemotherapy is a strategy of administering cytotoxic drugs at high frequency, low doses, and minimal downtime. Based on this, this study aims to evaluate the efficacy and safety of anti-PD1 monoclonal antibody combined with nimotuzumab and capecitabine in patients with recurrent or metastatic nasopharyngeal carcinoma who failed to first-line platinum-based chemotherapy, to provide new evidence for individualized comprehensive treatment in nasopharyngeal carcinoma.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Anti-PD1 antibody, nimotuzumab and capecitabine	Combination phase Anti-PD1 monoclonal antibody: Choose one of the anti-PD-1 monoclonal antibody drugs reimbursed by medical insurance, toripalimab (240mg), camrelizumab (200mg), tislelizumab (200mg) or others; Intravenous infusion, every 3 weeks . Nimotuzumab:: In the first 6 cycles, 200 mg, intravenous infusion, every 1 week, and 400 mg is administered for the first time. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks Maintenance phase: Anti-PD1 monoclonal antibody: anti-PD-1 monoclonal antibody drugs, Intravenous infusion, every 3 weeks. Nimotuzumab treatment: 400 mg, intravenous infusion, every 3 weeks. Capecitabine: 1000 mg/m2, orally twice daily on days 1-14, every 3 weeks； The duration of treatment is 1 year or until intolerable toxic reactions occur, or disease progresses, or the patient withdraws consent, or the investigator determines that the patient needs to withdraw from treatment.

Timeline

• Start date: 2024-02-10
• Primary completion: 2026-02-09
• Completion: 2026-08-09
• First posted: 2024-02-14
• Last updated: 2024-03-07

Locations

1 site across 1 country: China