RecruitingPhase 2NCT05097209

Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma

Camrelizumab Combined With Induction Chemotherapy and Intensity Modulated Radiotherapy for the Treatment of Locally Advanced Nasopharyngeal Carcinoma:a Randomized, Multicenter, Phase II Trial


Sponsor

Wei Jiang

Enrollment

200 participants

Start Date

Apr 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial plans to enroll patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or 3 cycles of induction chemotherapy with gemcitabine and cisplatin and radiation plus Camrelizumab. All patients will receive intensity-modulated radiotherapy (IMRT). Camrelizumab will begin on day 1 of induction chemotherapy every 3 weeks for 3 cycles and continue every 2 weeks for 9 cycles.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding camrelizumab — an immunotherapy drug that helps the immune system attack cancer — to standard chemotherapy and radiation can improve outcomes for people with locally advanced nasopharyngeal carcinoma (cancer at the back of the nose and throat). **You may be eligible if...** - You have been diagnosed with nasopharyngeal carcinoma, confirmed by biopsy - Your cancer is stage III or IVA (locally advanced but not yet spread to distant organs) - You are in reasonably good health (ECOG ≤ 1) - You are between 18 and 70 years old - Your blood counts, liver function, and kidney function are adequate - You are willing to use contraception for 1 year after the last dose **You may NOT be eligible if...** - You have active hepatitis B or C - You have active autoimmune disease requiring treatment - You are taking systemic corticosteroids - You have had prior treatment for nasopharyngeal cancer - 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

DRUGCamrelizumab

Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.

DRUGGemcitabine

Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation

DRUGInduction Cisplatin

Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation

RADIATIONintensity-modulated radiotherapy

Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

DRUGConcurrent cisplatin

Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation


Locations(5)

Guangxi Nanxishan hospital

Guilin, Guangxi, China

Guilin Medical University

Guilin, Guangxi, China

Laibin People's Hospital

Laibin, Guangxi, China

Linshan people's hospital

Linshan, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

View Full Details on ClinicalTrials.gov

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NCT05097209


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