NCT05060471已完成2 期
Neoadjuvant PD-1 Blockade Combined with Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年10月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- cCR rate
研究概览
简要总结
Locally Advanced Anal Canal Squamous Carcinoma Patients will be enrolled and given four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab. Treatment outcomes and toxicities will be evaluated.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Histology confirmed as anal canal squamous carcinoma;
- •Clinical stage I-III
- •No distant metastasis;
- •Age: 18-75 years old;
- •ECOG 0-1 score
- •Adequate bone marrow, liver, kidney function
- •if HIV infected, HIV loading is below the lower limit (<20 copy </ ml), with the number of CD4+T cells > 300> ml
- •Non-pregnant or lactating women;
- •No other malignant disease within 5 years before diagnosis of anal cancer squamous carcinoma (except endocervical cancer in situ or skin basal cell carcinoma which had been cured); no other malignant disease beside anal cancer squamous carcinoma
- •No other serious disease leading to shortened survival.
- •No previous anal canal surgery or anal tumor resection (except for biopsy);
- •No chemotherapy received within the previous 5 years;
- •No previous pelvic radiation;
- •No biological treatment received in the previous 5 years;
- •No previous immunotherapy received.
排除标准
- •Diagnosed as stage I and well differentiated squamous cell carcinoma
- •Distant metastasis
- •Received radiation therapy in abdominal or pelvic regions
- •Pregnant, lactating woman patient or fertile but lacks adequate contraceptives
- •Infectious disease: Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection
- •Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening;
- •Chronic inflammatory colorectal disease, unrelieved ileus
- •Dyscrasia or organ decompensation
- •Allergic to research-related drugs
- •Severe hypertension with poor drug control;
- •Epilepsy require medical treatment (such as steroid or antiepileptic therapy);
- •Drug abuse and medical, psychological or social factors that may interfere with patients' participation in the study or affect the evaluation of the study;
- •Patients have any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and decreased thyroid function; patients with vitiligo or with complete remission of asthma in childhood and without any intervention in adulthood may be included; patients with asthma requiring bronchodilators intervention are not included.
- •Received any anti-infection vaccine (e.g. influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment;
- •Complications require long-term treatment with immunosuppressive drugs, or requiring systemic or local use of immunosuppressive corticosteroids(>10mg/day prednisone or other therapeutic hormones);
- •Any unstable condition or which endangers the patients' safety and compliance;
- •Refuses to sign informed consent
研究组 & 干预措施
Intervetional group
Experimental
Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab
干预措施: Toripalimab (Drug)
结局指标
主要结局
cCR rate
时间窗: 3 months after treatment
cCR rate 3 months after treatment
次要结局
- cCR rate(6 months after treatment)
- late toxicities(3 months after treatment)
- distant metastasis rate(from the end of treatment to 5 years after treatment)
- progression free survival(from the end of treatment to 5 years after treatment)
- overall sruvival(from the end of treatment to 5 years after treatment)
- acute toxicities(from the start of treatment to 3 months after treatment)
- local recurrence rate(from the end of treatment to 5 years after treatment)
- colostomy rate(from the end of treatment to 2 years after treatment)
研究者
Yuan-hong Gao
Professor
Sun Yat-sen University
研究点 (1)
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