A Phase II Study of Radscopal Radiotherapy Combined With Immunotherapy as First-Line Treatment for Chemotherapy-Ineligible Patients With De Novo Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) of Primary Lesions
研究概览
简要总结
The RADIANCE trial plans to enroll patients with chemotherapy-ineligible de novo metastatic nasopharyngeal carcinoma (AJCC 9th edition, TxNxM1). Participants will receive Radscopal radiotherapy, consisting of low-dose radiotherapy to the primary lesions and stereotactic body radiotherapy to distant metastatic lesions, in combination with sintilimab and ipilimumab. The study will evaluate the objective response rate of the primary lesions, systemic disease control as measured by progression-free survival and overall survival, and the safety and tolerability of this treatment regimen.
The main questions this study aims to answer are:
Does this treatment improve efficacy with acceptable safety in chemotherapy-ineligible patients? Does Radscopal radiotherapy enhance systemic antitumor immunity, and what is the Radscopal Response Rate? What clinical and immunological factors are associated with the Radscopal effect, and what mechanisms may underlie this effect?
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 18-80 years.
- •2. Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma (TxNxM1 according to AJCC 9th edition), with ≤10 measurable metastatic lesions.
- •3. At least one measurable nasopharyngeal lesion suitable for low-dose radiotherapy and at least one distant metastatic lesion suitable for stereotactic body radiotherapy.
- •4. ECOG performance status 0-
- •5. PD-L1 combined positive score (CPS) ≥
- •6. Chemotherapy-ineligible, including patients medically unsuitable for platinum-based chemotherapy or patients who refuse standard platinum-based chemotherapy after being fully informed.
- •7. Life expectancy ≥6 months.
- •8. Adequate organ function, including ANC ≥1.0 × 10^9/L, platelets ≥75 × 10^9/L, hemoglobin ≥80 g/L, ALT/AST ≤3 × ULN, bilirubin ≤2 × ULN, creatinine clearance ≥30 mL/min, and LVEF ≥45% or normal echocardiography.
- •9. No major surgery within 1 month before enrollment.
- •10. No immunosuppressive or immunomodulatory therapy within 1 month before immune checkpoint inhibitor treatment.
- •11. Written informed consent and ability to comply with study procedures and follow-up.
排除标准
- •1. Age <18 years.
- •2. >10 metastatic lesions, meningeal metastasis, spinal cord compression, or lesions unsuitable for safe stereotactic body radiotherapy.
- •3. Other malignancy within 5 years, except cured basal cell carcinoma, squamous cell carcinoma of the skin, papillary thyroid carcinoma, or cervical carcinoma in situ.
- •4. Prior systemic immune checkpoint inhibitor therapy or prior nasopharyngeal radiotherapy.
- •5. Active hepatitis B infection, defined as HBsAg positivity with HBV DNA >200 IU/mL or >1000 copies/mL.
- •6. Positive hepatitis C virus antibody.
- •7. Active, known, or suspected autoimmune disease, except type 1 diabetes, hypothyroidism requiring only hormone replacement, or skin disorders not requiring systemic treatment.
- •8. Systemic corticosteroids equivalent to >10 mg prednisone daily or other immunosuppressive therapy within 28 days before informed consent, except low-dose, inhaled, or topical corticosteroids.
- •9. Active tuberculosis, active tuberculosis within the previous year, or prior active tuberculosis without documented adequate anti-tuberculosis treatment.
- •10. History of interstitial lung disease.
- •11. Uncontrolled diabetes mellitus (fasting blood glucose >13.9 mmol/L).
- •12. Live vaccine within 30 days before informed consent or planned live vaccination.
- •13. Known allergy to macromolecular protein preparations or to any component of sintilimab or ipilimumab.
- •14. HIV infection.
- •15. Any condition that may affect participant safety or compliance, including uncontrolled cardiovascular disease, active infection requiring systemic treatment, psychiatric illness, severe cognitive impairment, suicidal tendency, or relevant psychological, family, or social factors.
研究组 & 干预措施
Radscopal Radiotherapy Plus Sintilimab and Ipilimumab
Participants will receive LDRT to the primary lesions, SBRT to selected metastatic lesions, and intravenous sintilimab and ipilimumab.
干预措施: Radscopal Radiotherapy (Radiation)
Radscopal Radiotherapy Plus Sintilimab and Ipilimumab
Participants will receive LDRT to the primary lesions, SBRT to selected metastatic lesions, and intravenous sintilimab and ipilimumab.
干预措施: ipilimumab (Drug)
Radscopal Radiotherapy Plus Sintilimab and Ipilimumab
Participants will receive LDRT to the primary lesions, SBRT to selected metastatic lesions, and intravenous sintilimab and ipilimumab.
干预措施: Sintilimab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) of Primary Lesions
时间窗: 6 months
The proportion of participants with confirmed complete response or partial response in measurable primary lesions (nasopharyngeal and neck), assessed according to RECIST version 1.1.
次要结局
- Objective Response Rate by Lesion Irradiation Type(6 months)
- Disease Control Rate (DCR)(6 months)
- Duration of Response (DoR)(1 year)
- One-Year Progression-Free Survival (PFS)(1 year)
- One-Year Overall Survival (OS)(1 year)
- Adverse Events (AEs) and serious adverse events (SAEs)(1 year)
- Quality of Life (QoL): EORTC QLQ-C30(1 year)
- Quality of Life (QoL): EORTC QLQ-HN35(1 year)
研究者
Mao Yanping
Professor and Principal Investigator
Sun Yat-sen University