A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer
A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Biliary Cancer
研究概览
地位
条件
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Anhui
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Hefei、Anhui、中国、230001
- 尚未招聘
- Anhui Provincal Hospital
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接触:
- Yueyin Pan, Doctor
- 邮箱:yueyinpan1965@126.com
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Beijing
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Beijing、Beijing、中国、100044
- 尚未招聘
- Peking University People's Hospital
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接触:
- Lei Chen, Doctor
- 邮箱:chenlei@pkuoh.edu.cn
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首席研究员:
- Lei Chen, Doctor
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Beijing、Beijing、中国、100021
- 尚未招聘
- Cancer Hospital Chinese Academy of Medical Sciences
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首席研究员:
- Aiping Zhou, Doctor
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接触:
- Aiping Zhou, Doctor
- 电话号码:010-87788800
- 邮箱:zhouap1825@126.com
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Beijing、Beijing、中国、102218
- 尚未招聘
- Beijing Tsinghua Changgung Hospital
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接触:
- Jiahong Dong, Doctor
- 电话号码:010-56118888
- 邮箱:dongjiahong@mail.tsinghua.edu.cn
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首席研究员:
- Jiahong Dong, Doctor
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Beijing、Beijing、中国、100089
- 招聘中
- Beijing Cancer Hospital
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Beijing、Beijing、中国、100020
- 尚未招聘
- Beijing Chao-Yang Hospital,Capital medical university
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接触:
- Guangyu An, Doctor
- 邮箱:agybjcyyy@163.com
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首席研究员:
- Guangyu An, Doctor
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Beijing、Beijing、中国、100069
- 尚未招聘
- Beijing Youan Hospital,Captical Medical University
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接触:
- Dondong Lin, Doctor
- 邮箱:ldd1231@126.com
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首席研究员:
- Dondong Lin, Doctor
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Fujian
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Fuzhou、Fujian、中国、350001
- 尚未招聘
- Fujian Medical University Union Hospital
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接触:
- Xiaoyan Lin, Doctor
- 邮箱:xiaoyanlin@yahoo.com
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Hebei
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Baoding、Hebei、中国、071000
- 尚未招聘
- Affiliated Hospital of Hebei University
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首席研究员:
- Aimin Zang, master
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接触:
- Aimin Zang, master
- 邮箱:booszam@sina.com
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Cangzhou、Hebei、中国、061001
- 尚未招聘
- Cangzhou Central Hospital
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接触:
- Jinghua Gao, bachelor
- 邮箱:gaojinghua0317@163.com
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首席研究员:
- Jinghua Gao, bachelor
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Chengde、Hebei、中国、067000
- 尚未招聘
- Affiliated Hospital of Chengde Medical University
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接触:
- Qingshan Li, bachelor
- 邮箱:libing200865@126.com
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首席研究员:
- Qingshan Li, bachelor
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Heilongjiang
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Harbin、Heilongjiang、中国、150081
- 尚未招聘
- Harbin medical university affiliated tumor hospital
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首席研究员:
- Yanqiao Zhang, Doctor
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接触:
- Yanqiao Zhang, Doctor
- 邮箱:yanqiaozhang@126.com
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Henan
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Zhengzhou、Henan、中国、450003
- 尚未招聘
- Henan Tumor Hospital
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接触:
- Xiaobing Chen, Doctor
- 邮箱:2290773710@qq.com
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首席研究员:
- Xiaobing Chen, Doctor
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Hubei
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Wuhan、Hubei、中国、430040
- 尚未招聘
- Tongji Medical College of Hust
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接触:
- Hong Qiu, Doctor
- 邮箱:tjqiuhong@163.com
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首席研究员:
- Hong Qiu, Doctor
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Hunan
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Changsha、Hunan、中国、410000
- 尚未招聘
- Hunan Provincial People's Hospital
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接触:
- Chuang Peng, Doctor
- 邮箱:1518364280@qq.com
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首席研究员:
- Chuang Peng, Doctor
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Jiangsu
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Changzhou、Jiangsu、中国、213000
- 尚未招聘
- The First Peoples Hospital of Changzhou
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接触:
- Haijiao Yan, Doctor
- 邮箱:haijiao8237@163.com
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首席研究员:
- Haijiao Yan, Doctor
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Jilin
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Changchun、Jilin、中国、130000
- 尚未招聘
- The First Bethune Hospital of Jilin University
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接触:
- Wei Li, Doctor
- 邮箱:jdyylw@163.com
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首席研究员:
- Wei Li, Doctor
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 1. Histologically or cytologically confirmed biliary adenocarcinoma, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC).
2.18 years and older,Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;Weight ≥40 kg or BMI ≥18.5.
3. At least one measurable lesion (based on RECIST 1.1). 4. Previous first-line gemcitabine or fluorouracil-based combination chemotherapy failed.
5.Adequate laboratory indicators. 6. No pregnant or breastfeeding women, and a negative pregnancy test. 7. Understood and Signed an informed consent form.
Exclusion Criteria:
1. Tumor disease and medical history:
- Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
- Has other malignant tumors within 5 years;
- Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
- Severe bone damage caused by tumor bone metastasis;
- Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites;
- Partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved; 2. Previous anti-tumor therapy:
- Has received Anlotinib Hydrochloride Capsules, Bevacizumab Injection, and immune checkpoint inhibitors such as PD-1, PD-L1, and CTLA-4 in prior treatment;
- Have received anti-tumor therapy within 4 weeks before the first administration;
- Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 3.Comorbidities and medical history:
- Active hepatitis B or C;
- Kidney abnormalities;
- Abnormal thyroid function;
- Cardiovascular abnormalities;
- Gastrointestinal abnormalities;
- History of immunodeficiency;
- Has risk of bleeding;
- Uncontrollable active bacterial, fungal or viral infections;
- Lung diseases, such as interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm;
- Allergies to the ingredients of the study drug;
- Have a history of neurological or psychiatric disorders
- According to the researcher's point of view, other severe, acute or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study, or may interfere with the interpretation of the study results;
- Have a history of pituitary or adrenal dysfunction
- Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;
- Long-term unhealed wound or fracture;
Has drug abuse history that unable to abstain from or mental disorders; 4. Has participated in other clinical trials within 30 days before the study. 5. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
6. Pregnant or breastfeeding women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:TQB2450+Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
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TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
|
有源比较器:Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection.
Each cycle is 3 weeks.
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Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall survival (OS)
大体时间:up to 40 weeks
|
OS defined as the time from randomization to death from any cause.
Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
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up to 40 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
12 个月的总生存期
大体时间:长达 12 个月
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OS 至少达到 12 个月的参与者百分比。
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长达 12 个月
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Progression free survival (PFS)
大体时间:up to 24 weeks
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PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
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up to 24 weeks
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Overall response rate (ORR)
大体时间:up to 24 weeks
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Percentage of participants achieving complete response (CR) and partial response (PR).
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up to 24 weeks
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Disease control rate(DCR)
大体时间:up to 24 weeks
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Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
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up to 24 weeks
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Duration of response(DOR)
大体时间:up to 24 weeks
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The time when the participants first achieved complete or partial remission to disease progression.
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up to 24 weeks
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Progression-free survival at 6 months
大体时间:up to 6 months
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Percentage of participants whose PFS has achieved at least 6 months.
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up to 6 months
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Overall survival at 6 months
大体时间:up to 6 months
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Percentage of participants whose OS has achieved at least 6 months.
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up to 6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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TQB2450 Injection的临床试验
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.未知
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.尚未招聘
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Jiangxi Provincial Cancer HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.招聘中消化系统疾病 | 肠胃疾病 | 组织学类型的肿瘤 | 按部位分类的肿瘤 | 消化道肿瘤 | 消化系统肿瘤 | 癌,鳞状细胞 | 食道肿瘤 | 食道疾病 | 肿瘤,鳞状细胞 | 食管鳞状细胞癌中国
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.招聘中
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.终止
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.尚未招聘