RecruitingPhase 2NCT06259721

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


Sponsor

Jiangxi Provincial Cancer Hospital

Enrollment

22 participants

Start Date

Feb 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — an anti-PD1 immunotherapy, nimotuzumab (a drug targeting a growth protein on cancer cells), and capecitabine (an oral chemotherapy) — for people with nasopharyngeal carcinoma (a cancer of the back of the nasal passage) that has come back or spread despite prior platinum-based chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed recurrent or metastatic nasopharyngeal carcinoma - You have already received platinum-based chemotherapy and your cancer progressed - You have at least one measurable tumor on imaging - You are in good general health (ECOG score 0 or 1) - Your expected survival is at least 3 months - Your blood counts, liver, kidney, and other organ functions meet minimum requirements **You may NOT be eligible if...** - You have a known severe allergy to any of the study drugs - You have active autoimmune disease or chronic steroid use - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have significant heart, lung, or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnti-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.


Locations(1)

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

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NCT06259721


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