RecruitingPhase 3NCT05342792

Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma

Metronomic Capecitabine With or Without Tislelizuamb (PD-1 Antibody) as Adjuvant Therapy in High-risk Non-metastatic Nasopharyngeal Carcinoma: a Multicentre, Open-label, Randomised Phase 3 Trial


Sponsor

Sun Yat-sen University

Enrollment

556 participants

Start Date

Apr 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a PD-1 immunotherapy drug to metronomic capecitabine (low-dose oral chemotherapy given continuously) after chemoradiotherapy reduces the risk of nasopharyngeal carcinoma (a throat cancer) coming back in high-risk patients. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with high-risk, locally advanced nasopharyngeal carcinoma (non-keratinizing type) - You have already completed induction and concurrent chemoradiotherapy - You plan to start adjuvant therapy within 1–6 weeks of finishing radiotherapy - Your blood counts and organ function are normal - Your ECOG score is 0 or 1 **You may NOT be eligible if...** - You have not completed the required chemoradiotherapy - Your blood counts or organ function do not meet required levels - Your cancer has metastasized to distant organs 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

DRUGPD-1 antibody

Tislelizumab:200 mg per dose, intravenous infusion over 30 minutes, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy

DRUGCapecitabine

Capecitabine : 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05342792


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