RecruitingNCT05707819

Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

Sintilimab (PD-1 Antibody) in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Multicentre, Phase 2 Trial


Sponsor

Cancer Hospital of Guangxi Medical University

Enrollment

43 participants

Start Date

Jul 30, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) . Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug called sintilimab to standard chemotherapy and radiation improves outcomes for people with a specific type of throat/nasal cancer called nasopharyngeal carcinoma. **You may be eligible if...** - You have been diagnosed with a specific type of nasopharyngeal (nasal throat) cancer confirmed by biopsy - Your cancer is stage III or IVA (has spread to nearby tissue or lymph nodes but not distant organs) - You are between 18 and 70 years old - You are generally well enough to carry out daily activities with minimal limitations - Your liver, kidney, and blood counts are within acceptable ranges - You are willing to use contraception during treatment and for 1 year after **You may NOT be eligible if...** - You have active hepatitis B with high viral load, or hepatitis C - You have an active autoimmune disease (besides controlled type 1 diabetes, thyroid conditions, or minor skin conditions) - You have a history of serious lung disease such as interstitial lung disease - You have recently used high-dose steroids or immune-suppressing medications - You are pregnant, breastfeeding, or planning pregnancy during the study 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

DRUGSintilimab (PD-1 Antibody)

Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.


Locations(1)

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

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NCT05707819


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