A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- EFFICACY Progress-free survival (PFS)
研究概览
简要总结
This is a phase 2, single-arm clinical trial, with the purpose to evaluate the therapeutic efficacy and safety of PD-1 Blockade camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy and as adjuvant monotherapy in patients with locally advanced head and neck squamous cell carcinoma.
详细描述
All participants from 3 hospitals will receive induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
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
- •Males and females ≥18 years of age.
- •ECOG Performance Status 0 or
- •Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx or nasal sinus.
- •Stage III, IVa, IVb (according to the 8th AJCC edition); Stage III for HPV positive oropharyngeal disease.
- •Inoperable or refused surgery; eligible for definitive concurrent chemoradiotherapy.
- •With measurable target lesions by CT or MRI.
- •Adequate bone marrow function.
- •Adequate renal and liver function.
- •Pregnancy test (for patients of childbearing potential) negative at screening.
- •Signed Written Informed Consent.
排除标准
- •Have a history of immunodeficiency, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
- •Active autoimmune disease (Such as type I diabetes, vitiligo, psoriasis, patients who do not need immunosuppressive drugs do not need to be excluded).
- •Has abnormal thyroid function, and the thyroid function cannot be maintained normal despite medical treatment.
- •Pregnancy or breast feeding.
- •Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
- •Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
- •Has received a live vaccine within 4 weeks of planned start of study therapy.
- •Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
研究组 & 干预措施
Camrelizumab plus chemoradiotherapy
Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
干预措施: Camrelizumab (Drug)
Camrelizumab plus chemoradiotherapy
Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
干预措施: Concurrent cisplatin chemotherapy (Drug)
Camrelizumab plus chemoradiotherapy
Induction camrelizumab therapy at least one cycle (every 3 weeks) followed by definitive concurrent chemoradiotherapy. After 4~6 weeks of the completion of radiotherapy, adjuvant camrelizumab therapy will begin every 3 weeks for 16 cycles (1 year) or continue until progression or unacceptable toxicity.
干预措施: Intensity-modulated radiotherapy (IMRT) (Radiation)
结局指标
主要结局
EFFICACY Progress-free survival (PFS)
时间窗: 2 years
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
次要结局
- EFFICACY Objective response rate (ORR）(2 years)
- EFFICACY Duration of response (DOR)(2 years)
- SAFETY Incidence rate of adverse events (AEs)(2 years)
- QUALITY OF LIFE Quality of life (QoL): questionnaire(2 years)
- EFFICACY Overall survival (OS)(2 years)
研究者
Ying Wang
Associate Director of Chongqing University Cancer Hospital
Chongqing University Cancer Hospital