Gemcitabine + Docetaxel + Toripalimab Induction in Epstein-Barr Virus (EBV) Associated Nasopharyngeal Carcinoma(NPC)

Официальное название

A Safety, Feasibility and Efficacy Study of Gemcitabine Plus Docetaxel Plus Toripalimab (GDT) Induction as Part of a Curative Sequential Chemoradiation for Patients With Locoregional EBV Associated Nasopharyngeal Carcinoma (NPC)

Обзор

The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.

Вмешательства

• Препарат Toripalimab
  Toripalimab will be administered 240 mg intravenously every three weeks in combination with the induction chemotherapy regimen for 3 cycles, and for 9 cycles as adjuvant treatment following radiation as specified in the overall sequential treatment plan.
• Лучевая терапия Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation
  Radiation treatment will be initiated 3-6 weeks following day 1 of the last induction cycle using institutional standards of care and support as follows: Intensity modulated radiotherapy, 70 Gy in 33 fractions M-F once daily plus cisplatin 40 mg/m2 IV weekly for up to 7 doses. Following the completion of concurrent chemoradiation, capecitabine will be administered using institutional standards of care as follows: Capecitabine 650 mg/m2 PO BID x 12 months beginning 12 to 16 weeks following the

Первичные конечные точки

• Induction chemotherapy completion rate [Срок оценки: 3 years]
• Radiation completion rate [Срок оценки: 3 years]

Вторичные конечные точки (2)

• Overall Response (ORD) rate following induction [Срок оценки: 3 years]
• Complete Response (CR) rate following radiation [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
• Prior therapy: None for NPC permitted
• Life expectancy: 3 months at least
• Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.
• ECOG Performance Status of 0,1, or 2
• Age: At least 18 years old.

CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows:

• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥ 100,000 cells/mm3;
• Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);

Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows:

• Total bilirubin ≤ 1.5 x institutional ULN;
• AST and ALT ≤ 1.5 x institutional ULN;

Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:

• Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
• Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
• Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Критерии исключения

• Prior systemic anticancer treatment for NPC
• Prior radiation to head and neck region or regions necessitating overlapping fields
• Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
• History of allergic reactions to any agents in this study
• Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
• Pregnant or breastfeeding
• Severe, active co-morbidity, defined as follows:

• Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
• Unstable angina and/or uncontrolled congestive heart failure within past 6 months;
• Myocardial infarction within the last 6 months;
• Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
• Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
• ≥ grade 2 peripheral sensory neuropathy

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

США · 1 центр

• Stanford University — Palo Alto

Идентификаторы

NCT: NCT06592599 · IRB-75587 · NCI-2025-00939

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗