RecruitingPhase 3NCT06438627

Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial

Efficacy and Safety of Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab vs Gemcitabine, Cisplatin Combined With Camrelizumab for Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in High-Risk Nasopharyngeal Carcinoma: A Prospective, Controlled, Open-Label, Multicenter Phase 3 Clinical Trial


Sponsor

XIANG YANQUN

Enrollment

164 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study compares two chemotherapy regimens, each combined with the immunotherapy drug camrelizumab, in patients with high-risk nasopharyngeal carcinoma (a cancer of the back of the nose and throat) that has spread to lymph nodes. The goal is to find the best combination treatment before radiation therapy. **You may be eligible if...** - You have a confirmed diagnosis of nasopharyngeal carcinoma (WHO type II or III) - Your cancer is classified as stage TanyN3M0 (spread to distant lymph nodes but not other organs) - You have not received prior treatment for this cancer - You are between 18 and 65 years old - You are in good general health (ECOG performance status 0–1) - Your blood counts, liver function, and kidney function meet study requirements **You may NOT be eligible if...** - You are pregnant or in the perinatal period - You have known allergies to the study drugs - You have severe heart, lung, liver, or kidney dysfunction - You have HIV/AIDS, active hepatitis B or C, or a serious uncontrolled infection - You have a history of another cancer in the past 5 years (except certain treated skin cancers) 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

DRUGTPC combined with Apatinib and Camrelizumab

Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab

DRUGGP Combined With Camrelizumab

Gemcitabine, Cisplatin regimen Combined With Camrelizumab


Locations(2)

SunYat-senU

Guangzhou, Guangdong, China

Sun Yat sen Memorial Hospital

Guangzhou, China

View Full Details on ClinicalTrials.gov

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NCT06438627


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