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

Официальное название

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

Обзор

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.

Подробное описание

IMPORTANCE: Safe and effective therapies for untreated, advanced locally advanced nasopharyngeal carcinoma remain an unmet need.

OBJECTIVE: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.

Вмешательства

• Препарат TPC combined with Apatinib and Camrelizumab
  Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab
• Препарат GP Combined With Camrelizumab
  Gemcitabine, Cisplatin regimen Combined With Camrelizumab

Первичные конечные точки

• 3-years FFS [Срок оценки: up to 3 years]

Вторичные конечные точки (4)

• DMFS [Срок оценки: up to 3 years]
• OS [Срок оценки: up to 3 years]
• LRFS [Срок оценки: up to 3 years]
• ORR [Срок оценки: up to 3 years]

Критерии участия

Критерии включения

• Pathologically confirmed WHO type II or III;
• Staging TanyN3M0 (UICC/AJCC 8th edition);
• Treatment-naive patients with no history of other malignancies;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Age 18-65 years;
• Neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90 g/L, transaminases <2.5 times the upper limit of normal, total bilirubin <1.5 times the upper limit of normal, creatinine <1.5 times the upper limit of normal; activated partial thromboplastin time and international normalized ratio <1.5 times the upper limit of normal;
• Signed informed consent form.

Критерии исключения

• Known or suspected allergy to the study drugs, or pregnant/perinatal women;
• Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons;
• Severe dysfunction of critical organs such as the heart, lungs, liver, or kidneys (e.g., decompensated heart, lung, renal, or liver failure) that precludes tolerance to chemoradiotherapy;
• Severe uncontrolled infection or internal medical disease;
• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B defined as HBV-DNA ≥500 IU/ml, exclusion if normal liver function and on antiviral medication for more than one week; hepatitis C defined as HCV-RNA above the lower limit of detection) or coinfection with hepatitis B and C;
• Factors affecting drug administration, distribution, metabolism, or excretion such as psychiatric disorders, central nervous system abnormalities, chronic diarrhea, ascites, or pleural effusion;
• Poorly controlled hypertension despite antihypertensive treatment (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg);
• Long-term use of immunosuppressants post-organ transplantation;
• Known history of substance abuse or drug addiction;
• History of other malignancies prior to enrollment;
• Presence of other severe physical or mental illnesses or abnormal laboratory findings that may increase the risk of study participation, interfere with study results, or deemed unsuitable for participation by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• SunYat-senU — Гуанчжоу
• Sun Yat sen Memorial Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06438627 · SYSKY-2024-267-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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