De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC

Официальное название

The Exploratory Study of the Feasibility of De-escalating Radiation Strategy After NAC in Combination With Immunotherapy in LAHNSCC

Обзор

This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.

Вмешательства

• Препарат immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin
  The immunotherapy drug was pembrolizumab at a dose of 200 mg, administered on the first day of each cycle every 3 weeks. The induction chemotherapy regimen included albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every 3 weeks, either concurrently with immunotherapy or on the second day.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: 1 year]

Вторичные конечные точки (4)

• Overall survival (OS) [Срок оценки: 3-year]
• Clinical response rate [Срок оценки: 6 months]
• Safety(Grade 3-5 AE) [Срок оценки: 1-year]
• Quality of life [Срок оценки: 6 month and 1 year after the treatment]

Критерии участия

Критерии включения

• ≥18 years old, with medical decision-making capacity
• Signed informed consent
• ECOG score of 0-1
• Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer
• Exclusion of distant metastasis
• Clearly evaluable lesion (per RECIST 1.1 criteria)
• Expected life span ≥6 months
• Laboratory test results meet the following requirements: WBC ≥ 3×10\^9/L, ANC ≥ 2.0×10\^9/L, PLT ≥ 80×10\^9/L, Hb ≥ 80g/L (according to the normal standards of the central laboratory); Liver function: Total bilirubin, ALT, and AST all ≤ 1.5x UNL (upper normal limit); AST (SGOT)/ALT (SGPT) ≤ 2.5 x IULN (upper normal limit); Kidney function: Cr ≤ 1.5x UNL (upper normal limit), and creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft and Gault formula); Thyroid function T3 and T4 within the normal range (hypothyroidism can be corrected with oral thyroid hormone supplementation); Heart function: All three cardiac enzymes and pro-BNP within the normal range, no history of heart attack; Adrenal function: Normal cortisol secretion function or correctable based on endocrine assessment
• HBV-infected patients with HBV-DNA copy numbers less than 500 IU/ml
• No history of other malignant tumors in the past 5 years (excluding basal cell carcinoma of the skin and thyroid cancer).

Критерии исключения

• No indications for curative radiotherapy or contraindications to radiochemotherapy.
• Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors).
• Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study.
• Previous history of autoimmune diseases or in the active phase of the disease \[including but not limited to inflammatory bowel disease (IBD), rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barré syndrome)\], vitiligo, and correctable endocrine deficiencies such as hypothyroidism and physiological cortisol deficiency can be included in the study and are not exclusion criteria.
• History of active tuberculosis or non-infectious pneumonia or any clinical evidence.
• Active phase of viral hepatitis, HBV DNA > 500 IU/ml.
• Acquired Immunodeficiency Syndrome (AIDS).
• Concurrent severe medical conditions (including heart diseases) with coexisting diseases or conditions affecting the patient's normal enrollment or safety during the study.
• Prior immunotherapy for other tumors.
• History of other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin or thyroid cancer).
• Pregnant or lactating women.
• Concurrently suffering from other malignant tumors.
• Cannot or unwilling to sign the informed consent form.
• Vaccination within 4 weeks.
• Allergic reaction to the investigational drug.

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

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06572514 · LAHNSCC-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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