NCT04895345Unknown2 期
An Open, Single-arm, Single-center, Phase II Clinical Trial of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a study to evaluate the efficacy and safety of TQB2450 injection combination with Intensity-modulated Radiotherapy in patients with inoperable locally recurrent nasopharyngeal carcinoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understood and Signed an informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;
- •Local recurrence of non-keratinizing nasopharyngeal carcinoma diagnosed by histopathology and/or cytology; Clinical stage: rT2-4N0-3M0 , RII-IVa phase (AJCC eighth edition);
- •The recurrence time is more than 12 months from the end of the first course of radiotherapy, without other systemic or local anti-tumor treatment;
- •At least one measurable lesion (based on RECIST 1.1);
- •Adequate laboratory indicators;
- •No pregnant or breastfeeding women, and a negative pregnancy test.
排除标准
- •Operable patients with local recurrence, including rT2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery > 0.5 cm) and rT3 (the tumor is confined to the bottom wall of the sphenoid sinus, and the distance from the internal carotid artery and cavernous sinus > 0.5 cm) ; 2.Combined diseases and medical history:
- •Accompanied by nasopharyngeal necrosis, radiation brain injury, severe neck fibrosis, or other ≥grade 3 radiation complications, the investigator has assessed that the risk is extremely high and not suitable for radiotherapy;
- •Has other malignant tumors within 3 years;
- •Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
- •Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;
- •Long-term unhealed wounds or fractures;
- •Arterial/venous thrombosis events occurred within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral; hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- •Has drug abuse history that unable to abstain from or mental disorders;
- •Has any severe and/or uncontrollable disease. 3.Tumor-related symptoms and treatment:
- •Diagnosed local recurrence and received surgery, chemotherapy, radiotherapy or other anti-cancer therapies before first administration;
- •Has received NMPA approved Chinese patent medicines with anti-tumor indications;
- •Has received relevant immunotherapy drugs for PD-1, PD-L1, CTLA-4, etc.;
- •Uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (as judged by the investigator); 4.Research and treatment related:
- •Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration;
- •Have severe hypersensitivity after using monoclonal antibodies;
- •Active autoimmune diseases that require systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the start of the study treatment;
- •Has immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy, and continue to use within 2 weeks of the first administration; 5.Has participated in other anti-tumor drug clinical trials within 4 weeks before the study; 6.According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB2450+Intensity modulated radiotherapy
Experimental
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day；The total dose of radiotherapy should meet PTVnx: 60Gy/27Fr/2.22Gy, PTVnd: 60-64Gy/27Fr/2.22-2.37Gy, PTV1: 54Gy/27Fr/2.00Gy, once a day, 5 times/week.
干预措施: TQB2450 (Drug)
TQB2450+Intensity modulated radiotherapy
Experimental
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day；The total dose of radiotherapy should meet PTVnx: 60Gy/27Fr/2.22Gy, PTVnd: 60-64Gy/27Fr/2.22-2.37Gy, PTV1: 54Gy/27Fr/2.00Gy, once a day, 5 times/week.
干预措施: Intensity modulated radiotherapy (Radiation)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 48 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
次要结局
- Disease control rate（DCR）(up to 48 weeks)
- Duration of Response (DOR)(up to 48 weeks)
- Progression-free survival (PFS)(up to 48 weeks)
- 12-month progression-free survival rate(up to 48 weeks)
- 12-month survival rate(up to 48 weeks)
- 24-month survival rate(up to 96 weeks)
- Local regional recurrence-free survival (LRRFs)(up to 48 weeks)
- Distant metastasis-free survival (DMFS)(up to 48 weeks)
- Overall survival (OS)(up to 96 weeks)
研究者
研究点 (1)
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