NCT05374252招募中3 期
A Phase 3, Multicenter, Double-Blind Randomized Study of Mitomycin, 5-Fluorouracil and IMRT Combined With or Without Anti-PD-1 in Patients With Locally Advanced Anal Canal Squamous Carcinoma
Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年5月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This is a phase III, multi-center, double-blind randomized controlled trial assessing the efficacy and safety of concurrent mitomycin C/5-Fu chemotherapy and long-course IMRT combined with PD-1 antibody Sintilimab for locally advanced anal canal squamous carcinoma patients, by comparing an experiment group (traditional chemoradiotherapy with PD-1 antibody Sintilimab) with a control group (traditional treatment without Sintilimab).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology identified anal canal squamous carcinoma,
- •Aged 18 to 75,
- •Clinical staging III, Eastern Cooperative Oncology Group 0-2 score,
- •The Staging method: All patients undergoing rectal anus palpation, high resolution MRI and chest-abdominal enhanced CT, clinical data should be re-evaluated and inclusive by center evaluation group when there is contradictory staging, distant metastasis were excluded by chest-abdominal enhanced CT and pelvic enhanced MRI,
- •No previous anal canal surgery or anal tumor resection (except for biopsy),
- •No previous chemotherapy or pelvic radiotherapy history,
- •No biopharmaceutical treatment history (such as monoclonal antibody), immunotherapy (such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment in the previous 5 years,
- •Adequate bone marrow, liver, and kidney function,
- •Clinical complete response (cCR) (Chest, abdominal and pelvic enhanced CT or pelvic enhanced MRI or PET/CT),
- •Informed consent assigned, Final inclusion criteria,
- •Non-pregnant or breast-feeding 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.
排除标准
- •Diagnosed as stage I-II 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,
- •Arrhythmia need anti-arrhythmia treatment (except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia (myocardial infarction within 6 months) or congestive heart-failure (CHF) > New York Heart Association grade II,
- •Severe hypertension not well controlled by drugs,
- •Active phase of chronic hepatitis B or hepatitis C (high copies of virus DNA),
- •Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening,
- •Other active clinical severe infection (NCI-CTCAE (version 4.0) ),
- •Dyscrasia, organ dysfunction,
- •Known or suspicious allergy to any research-related drugs,
- •Epilepsy needs treatments (Steroid or anti-epilepsy therapy),
- •Other malignant tumor history within 5 years,
- •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 restricted: 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,
- •Any anti-infection vaccine 4 weeks before inclusion,
- •Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose>10mg/day prednisolone or equivalent hormone),
- •Any unstable state might endanger the patients' safety and compliance,
- •Refuses to sign informed consent.
研究组 & 干预措施
Experimental Group
Experimental
Concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil, and IMRT, followed by adjuvant sintilimab
干预措施: PD-1 inhibitor (Drug)
Control Group
Active Comparator
Concurrent mytomicin C and 5-fluorouracil combined with IMRT
干预措施: concurrent chemoradiotherapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: from the end of treatment to 3 years after treatment
progression free survival
Overall survival
时间窗: from the end of treatment to 3 years after treatment
overall survival
cCR rate
时间窗: 6 months after treatment
cCR rate 6 months after treatment
次要结局
- Acute toxicities(from the start of treatment to 3 months after treatment)
- Colostomy rate(2 year)
- Local recurrence rate(from the end of treatment to 3 years after treatment)
- Distant metastasis rate(from the end of treatment to 3 years after treatment)
- cCR rate(3 months after treatment)
- The rate of late toxicity according to the RTOG/EORTC scale(3 years)
- Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events(1 year)
研究者
研究点 (1)
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