NCT04523883Unknown2 期
Randomized Phase II Trial of Postoperative Radiotherapy With Concurrent JS001（PD-1 Antibody） vs. Postoperative Radiotherapy Alone in Intermediate/High-risk Head and Neck Cancer Patients With a Contraindication to Cisplatin
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2020年8月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, hypopharynx , or sinuses (excluding nasopharynx)
- •With at least one risk factors after radical surgery ①positive margin; ②close margin（<5mm); ③ENE;④PNI;⑤LVI; ⑤ pT3-4/N2-3( AJCC 8th).⑥ Level IV/V lymph node metastases for OPC or OC.
- •Have at least one contraindication to cisplatin as defined:
- •① Age>65 years old; ②Creatinine clearance (CC) > 30 and < 60 cc/min For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female)* ((140-Age) / (Serum Creatinine)) * (Weight in kg / 72); ③ Zubrod performance status 2; ④Pre-existing peripheral neuropathy grade ≥ 1; ⑤History of hearing loss, defined as either: ▪ Existing need of a hearing aid OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated.
- •No distant metastases
- •No synchronous or concurrent head and neck primary tumors
- •ECOG PS 0-2
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
- •Platelets count >= 80 * 10^9/l
- •Hemoglobin >= 80 g/dl
- •AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- •Total bilirubin <= 1.5 times institutional ULN
- •Creatinine clearance >30 ml/min
- •Signed written informed consent
排除标准
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- •Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- •Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment
- •Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;
研究组 & 干预措施
concurrent PD-1
Experimental
Concurrent Immunotherapy With Postoperative Radiotherapy
干预措施: postoperative radiotherapy (Radiation)
concurrent PD-1
Experimental
Concurrent Immunotherapy With Postoperative Radiotherapy
干预措施: JS001 (Drug)
Radiotherapy alone
Active Comparator
Postoperative Radiotherapy alone
干预措施: postoperative radiotherapy (Radiation)
结局指标
主要结局
Disease free survival
时间窗: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
次要结局
- Overall survival(from date of enrollment until death from any cause, assessed up to 2 years)
- Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment(up to 3 months after completion of radiotherapy)
- Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0(from 3 months after completion of radiotherapy up to 2 years)
研究者
研究点 (1)
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