RecruitingPhase 3NCT06277050

Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

Maintenance Therapy With Toripalimab Combined With Capecitabine Versus Maintenancetherapy With Capecitabine Alone in High-risk Nasopharyngeal Carcinoma: a Multicenter, Prospective, Randomized Phase III Clinical Trial (NPC-ICMB)


Sponsor

Jiangxi Provincial Cancer Hospital

Enrollment

264 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure. The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (toripalimab) to standard maintenance chemotherapy (capecitabine) after initial treatment works better than capecitabine alone for high-risk nasopharyngeal carcinoma (a type of head and neck cancer). **You may be eligible if...** - You are between 18 and 70 years old with confirmed nasopharyngeal carcinoma - Your cancer is classified as high-risk (advanced lymph node spread, certain virus markers, or specific features) - You have already received induction chemotherapy plus concurrent chemoradiation - Your blood counts, liver, kidney, and organ function are adequate **You may NOT be eligible if...** - Your cancer has spread (recurrent or metastatic disease) - You have a history of another malignancy in the past 5 years - You have had prior immunotherapy or other conflicting treatments - You are pregnant or breastfeeding 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

DRUGMaintenance Therapy with Toripalimab and Capecitabine

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. Maintenance therapy of Toripalimab (240 mg, every 3 weeks). The total treatment time of oral chemotherapy is 12 months.

DRUGMaintenance Therapy with Capecitabine

Capecitabine maintenance therapy (1000 mg/m2 orally twice daily on days 1-14) every 3 weeks. The total treatment time of oral chemotherapy is 12 months.


Locations(3)

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

First Affiliated hospital of Gannan Medical University

Guangzhou, Jiangxi, China

Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital

Nanchang, None Selected, China

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NCT06277050


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