NCT06572514招募中1 期
The Exploratory Study of the Feasibility of De-escalating Radiation Strategy After NAC in Combination With Immunotherapy in LAHNSCC
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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).
排除标准
- •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.
研究组 & 干预措施
experimental arm
Experimental
Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy.
干预措施: immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 1 year
Progression-free survival (PFS) (local-regional recurrence) is defined as the time from enrollment to the occurrence of local or regional lymph node recurrence or death for any reason.
次要结局
- Quality of life(6 month and 1 year after the treatment)
- Overall survival (OS)(3-year)
- Clinical response rate(6 months)
- Safety(Grade 3-5 AE)(1-year)
研究者
GAOYUNSHENG
Principal Investigator
Ruijin Hospital
研究点 (1)
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