NCT06199973进行中（未招募）3 期
Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Progressive free survive assessed by Independent Review Committee
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Unresectable locally advanced or distant metastatic RAS/RAF wild-type colorectal cancer diagnosed histologically or cytologically;
- •After treatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure) ;
- •According to the response evaluation criteria for solid tumors (RECIST 1.1) , having at least one measurable lesion, measurable lesions should not have received local treatment such as radiotherapy (lesions located within the previously treated area may also be targeted if progression is confirmed) .
- •ECOG physical strength score: 0-1;
- •Expected survival was ≥12 weeks;
- •24-hour urine protein ≤1.0 g d) clotting: activated partial thromboplastin time (APTT) and international standard ratio (INR )≤1.5 × ULN (for use of a stable dose of anticoagulant therapy such as LMWH or Warfarin and INR can be screened within the expected range of anticoagulant therapy) ;
- •Eligible fertile patients (men and women) must agree to use a highly effective contraceptive method with their partner for at least 7 months during the trial and after the last dose; women of reproductive age must have a negative blood pregnancy test within 7 days before the first use of the study drug;
- •The subjects volunteered to join the study, signed the informed consent, good compliance, with follow-up.
排除标准
- •Subjects on systemic therapy with corticosteroid (> 10 mg daily equivalent of prednisone) or other immunosuppressive agents, except for local inflammation and the prevention of allergy and nausea and vomiting, who had undergone major surgery or severe trauma within 4 weeks prior to the first corticosteroid of the study drug, or who required elective surgery during the trial, who had undergone minor traumatic surgery, such as needle biopsy, within 7 days prior to the first dose of the study drug;
- •Previous allergies to monoclonal antibody, formulation components of SHR-A1811 products, and fluorouracil medications;
- •Previous antineoplastic therapy toxicities did not revert to a CTCAE v5.0 grade rating of ≤1(except for toxicities that the investigator judged to have no safety risk, such as alopecia, etc.) or the level specified by the enrollment/exclusion criteria;
- •Subjects with a history of meningeal metastasis or current meningeal metastasis; active brain metastasis;
- •uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- •history of immunodeficiency, these included people who tested positive for HIV or who had a fever of > 38.5 degrees of unknown cause before the first dose (cancer fever, as judged by the researchers, could be enrolled); Severe infection (CTCAE > Grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. Baseline chest imaging showed active pulmonary inflammation, active hepatitis B (HBV DNA ≥500 IU/mL) and hepatitis C (HCV-RNA was higher than the lower limit of detection);
- •Other malignancies in the past 5 years, not including cured skin basal-cell carcinoma and carcinoma in situ of the cervix;
- •Pregnant or lactating women.
研究组 & 干预措施
SHR-A1811
Experimental
干预措施: SHR-A1811 (Drug)
physician choiced treatment
Experimental
include: TAS-102, or Regorafenib, or Fruquintinib
干预措施: TAS-102, Regorafenib , Fruquintinib (Drug)
结局指标
主要结局
Progressive free survive assessed by Independent Review Committee
时间窗: Every 6 weeks, up to 3 years
次要结局
- Effectiveness: progressive free survive assessed by the researchers(Every 6 weeks, up to 3 years)
- Security: adverse events(The first day of each cycle（21 days or 28 days）)
- Effectiveness: objective response rate assessed by the researchers(Every 6 weeks, up to 3 years)
- Effectiveness: duration of response assessed by the researchers(Every 6 weeks, up to 3 years)
- Effectiveness: overall survive assessed by the researchers(Every 6 weeks, up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing RegimenHER2-positive Advanced Gastric Cancer or Gastroesophageal Junction AdenocarcinomaNCT06123494Jiangsu HengRui Medicine Co., Ltd.360
进行中（未招募）
2 期
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract CancerHER2 Expression / Amplification in Patients With Biliary Tract CancerNCT06413745Jiangsu HengRui Medicine Co., Ltd.59
Enrolling By Invitation
2 期
A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing CancersAdvanced Solid TumorsNCT05349409Suzhou Suncadia Biopharmaceuticals Co., Ltd.212
招募中
1 期
Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast CancerBreast CancerNCT06222879Shandong Suncadia Medicine Co., Ltd.350
招募中
2 期
A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer PatientsHER2-positive Breast CancerNCT05635487Shengjing Hospital65