NCT07454720招募中2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study of Adebrelimab Combined With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Resectable Rectal Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Phase II: pCR (Pathological Complete Response) rate
研究概览
简要总结
The study is being conducted to evaluate the safety and efficacy of Adebrelimab and SHR-8068 in combination with chemoradiotherapy in subjects with rectal cancer.
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
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- •Male or female ≥ 18 years old and ≤75 years old.
- •ECOG performance status of 0-
- •An assessment of resectable locally advanced rectal.
- •Has not received any anti-tumor treatment for rectal cancer.
- •With a life expectancy of ≥2 years.
- •Male participants whose partners are fertile women and fertile female participants must take effective contraceptive measures together with their partners from the time of signing the informed consent form until 6 months after the last administration of the investigational drug or the last radiotherapy. Female participants with fertility must have a negative serum or urine test for human chorionic gonadotropin (HCG) within 7 days before the first administration of the drug (if the serum HCG test is positive, pregnancy should be ruled out and further discussion with the sponsor should be conducted), and they must be not in the lactation period.
排除标准
- •Patients with rectal cancer who have experienced local recurrence after previous treatment.
- •Patients with concurrent colon tumors.
- •Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery.
- •Clinical or imaging examinations suggest the presence of intestinal obstruction or perforation, or those assessed by researchers as having a relatively high risk of perforation or bleeding.
- •With distant metastases.
- •Imaging examination of rectal cancer indicated positive lateral lymph nodes.
- •Having received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for tumors.
- •Female participants who are pregnant, breastfeeding or planning to become pregnant during the study period.
- •There are uncontrollable mental illnesses and other circumstances known to affect the completion of the research procedures, such as alcohol abuse, drug abuse or drug abuse, and criminal detention.
- •Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.
研究组 & 干预措施
Cohort 2
Experimental
Patients will receive radiotherapy and Adebrelimab combined with chemotherapy as perioperative treatment.
干预措施: Adebrelimab combined with chemotherapy (Drug)
Cohort 3
Experimental
Patients will receive radiotherapy plus chemotherapy as perioperative treatment.
干预措施: Chemotherapy (Drug)
Cohort 1
Experimental
Patients will receive radiotherapy and Adebrelimab in combination with SHR-8068 and chemotherapy as perioperative treatment.
干预措施: Adebrelimab in combination with SHR-8068 and chemotherapy (Drug)
结局指标
主要结局
Phase II: pCR (Pathological Complete Response) rate
时间窗: 12 months
Evaluated by investigators.
phase II：pCR（Pathological Complete Response） rate
时间窗: 12 months
Evaluated by investigators
次要结局
- Phase II: Clinical complete response (cCR) rate(60 months)
- Phase II: Disease-free survival (DFS)(60 months)
- Phase II: EFS (Event Free Survival)(60 months)
- Phase II: Tumor regression grade (TRG)(60 months)
- Phase II: R0 resection rate(60 months)
- Phase II: length of hospital stay(60 months)
- Phase II: Overall survival (OS)(60 months)
- Phase II: Perioperative mortality (within 30 days and 90 days after surgery)(60 months)
- Phase II:Disease-free survival (DFS);(60 months)
- Phase II： Clinical complete response (cCR) rate;(60 months)
- Phase II：EFS（Event Free Survival ）;(60 months)
- Phase II： Tumor regression grade (TRG);(60 months)
- Phase II： R0 resection rate;(60 months)
- Phase II： length of hospital stay;(60 months)
- Phase II： Overall survival (OS)(60 months)
- Phase II： Perioperative mortality (within 30 days and 90 days after surgery)(60 months)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
3 期
A Trial of SHR-A2102 With Adebrelimab in Locally Advanced or Metastatic Urothelial CarcinomaNCT07393542Suzhou Suncadia Biopharmaceuticals Co., Ltd.453
尚未招募
2 期
Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast CancerNCT07317778Cancer Institute and Hospital, Chinese Academy of Medical Sciences249
尚未招募
不适用
Adebrelimab Neoadjuvant Treatment for Resectable ESCCNCT07388095Tianjin Medical University Cancer Institute and Hospital22
招募中
2 期
Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line TherapyNCT07309185Shandong Tumor Hospital66
招募中
不适用
A Real-World Study Evaluating the Efficacy and Safety of Adebrelimab in Patients With Advanced SCLCNCT07434518Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine500