GEP Combined With Radiotherapy in Non-locally Treatable Recurrent NPC

Официальное название

A Prospective, Single-arm Phase II Clinical Study of GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy in Non-locally Treatable Recurrent Nasopharyngeal Carcinoma

Обзор

This research aims to assess both effectiveness and safety of combining R-GEP regimen comprising gemcitabine, recombinant human endostatin, and cerexinib with low- and high-dose radiotherapy in managing unresectable recurrent nasopharyngeal carcinoma.

Подробное описание

Eligible patients will undergo screening before enrolling in this trial 。 The participants will receive R-GEP therapy according to specified dosing schedules over six cycles. Additionally administered low-dose radiotherapy during specific cycles serves to modulate immune microenvironment while high-dose fractionated radiotherapy follows completion of GEP therapy courses. Maintenance immunotherapy continues up until one year post-treatment conclusion or disease progression.Finally, the participants were evaluated accordingly。

Вмешательства

• Препарат GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy
  The R-GEP regimen is as follows: Gemcitabine (G; 1.0 g/m2, d1, d8) in combination with recombinant human vascular endothelial growth factor (E; 150 mg, continuous intravenous infusion for 72 hours) and Carelizumab (P; 200 mg), administered every three weeks for a total of six cycles. During the 2nd-4th cycles, low-dose radiotherapy is administered to modulate the immune microenvironment (R: one course of radiotherapy per cycle: including booster fractions of 1 Gy\*3 times for the recurrent lesio

Первичные конечные точки

• 3 year OS rate [Срок оценки: 3 year]

Вторичные конечные точки (3)

• ORR [Срок оценки: 3year]
• DCR [Срок оценки: 3year]
• 3 year PFS rate [Срок оценки: 3 year]

Критерии участия

Критерии включения

• Patients aged ≥18 years;
• ECOG performance status 0-2;
• Pathological or clinical imaging diagnosis of recurrent nasopharyngeal carcinoma;
• With imaging assessable lesions (assessed by RECIST 1.1 criteria);
• Recurrent lesions are not eligible for curative local treatment (including but not limited to extensive invasion of recurrent lesions; recurrent lesions with obvious necrosis or ulceration, with bleeding risk; recurrent lesions extensively invading surrounding nerves/vessels or skin/muscle; obvious late radiation therapy complications after previous treatment: radiation-induced brain injury, posterior cranial nerve injury, dysphagia, severe myofibrosis; second or multiple courses of radiation therapy after recurrence or multiple recurrences);
• The following requirements must be met for the function of major organs:

Hematological parameters tolerable to treatment: white blood cells ≥3.0×10\^9/L, neutrophils ≥1.5×10\^9/L, hemoglobin ≥9 g/dL, platelets ≥90×10\^9/L.

Liver and kidney function: ALT, AST <1.5 times the upper limit of normal (ULN), total bilirubin <1.5×ULN, serum creatinine (Cr) ≤1.5×ULN; Echocardiographic assessment, left ventricular EF ≥50%;

• The patient has signed an informed consent form and is willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other research procedures.
• Voluntarily enroll in this study, sign an informed consent form, have good compliance and willingness to cooperate with follow-up.

Критерии исключения

• Subjects who cannot accept or tolerate chemotherapy or radiotherapy for various reasons;
• Subjects who can be cured by definitive radiotherapy or surgery;
• Subjects who have undergone major surgical procedures within the past 4 weeks or have not fully recovered from such procedures;
• Subjects who are currently participating in other drug clinical trials;
• Serious cardiac disease or discomfort, including but not limited to the following conditions:

• History of congestive heart failure or impaired systolic function (LVEF <50%);
• Uncontrolled high-risk arrhythmias, such as atrial tachycardia, resting heart rate >100bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular conduction block (i.e., Mobitz Ⅱ second-degree atrioventricular conduction block or third-degree atrioventricular conduction block);
• Angina requiring anti-angina drug therapy;
• Clinically significant valvular heart disease;
• ECG showing a penetrating myocardial infarction;
• Uncontrolled hypertension (systolic blood pressure >180mmHg and/or diastolic blood pressure >100mmHg);
• Subjects who have a history of hypersensitivity to any component of the study drug;
• Any other situation in which the investigator deems the subject unsuitable to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06611826 · IRB-2024-766（IIT）

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗