Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy
2020年9月14日 更新者:Chengdu Kanghong Biotech Co., Ltd.
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of Weekly Paclitaxel With or Without KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
The purpose of this study is to evaluate the efficacy and safety of the study drug known as KH903 in participants with gastric and gastroesophageal cance
研究概览
研究类型
介入性
注册 (预期的)
81
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 1.Prior to any detailed procedures of this study, subjects are able to understand, voluntarily participate in and sign the informed consent approved by the ethics committee.
- 2.Age ≥ 18 years.
- 3.Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma .
- 4.Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
- 5.Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum or/and fluoropyrimidine doublet for unresectable or metastatic disease.Second line chemotherapy is suitable for paclitaxel.
- 6.Laboratory test values must meet the following criteria. ANC ≥1.5×109/L, platelets ≥ 100×109/L, hemoglobin≥9g/dL. Blood creatinine ≤ 1.5 ×ULN or creatinine clearance ≥ 50 mL/min/m2. Total bilirubin ≤ 1.5× ULN(≤ 3 x ULN if Gilbert disease), AST and ALT ≤ 2.5× ULN (≤ 5×ULN if hepatic metastasis).
INR ≤ 1.5× ULN, APTT ≤ 1.5× ULN. Dipstick proteinuria <2+ or 24 hour proteinuria <1g .
- 7.Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1.
- 8.Life expectancy of ≥ 3 months.
Exclusion Criteria:
- 1.Histologically confirmed squamous cell carcinoma or undifferentiated gastric cancer.
- 2.Patients with disease progression within 6 months after previous adjuvant or neoadjuvant chemotherapy with paclitaxel, or patients with recurrent or metastatic gastric adenocarcinoma or GEJ adenocarcinoma treated with paclitaxel.
- 3. GI perforation and/or fistulae in the 6 months preceding randomization.
- 4.Deep-vein thrombosis, pulmonary embolism (PE), or any other episode of Uncontrolled thromboembolism in the 6 months preceding randomization.
- 5.Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack)
- 6.Uncontrolled hypertension (≥150/100 mm Hg ) despite properly observed antihypertensive therapy.
- 7.Known brain metastasis.
- 8.Known allergy to paclitaxel or KH903.
- 9.Serious concurrent infection or medical illness.
- 10.Active hepatitis B virus or Active hepatitis C virus (HCV) infection at screening.
- 11.Any condition which results in an undue risk for the patient during the trial participation according to the investigator.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:KH903 + Paclitaxel
IV KH903 4 mg/kg IV paclitaxel 80 mg/m²
|
KH903 4 mg/kg will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle; Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle
|
有源比较器:Placebo + Paclitaxel
IV Placebo IV paclitaxel 80 mg/m²
|
Placebo will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle; Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle
|
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 |
---|---|---|
Progression-free survival(PFS)
大体时间:Time from date of randomization until the date of first documented Progression or date of death from any cause, whichever came frist,assessed up to18 months
|
Date of randomization until the date of first documented Progression or date of death from any cause, whichever came first
|
Time from date of randomization until the date of first documented Progression or date of death from any cause, whichever came frist,assessed up to18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Objective Response Rate (ORR)
大体时间:Time from date of randomization until the date of first documented CR or PR,assessed up to18 months
|
Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR)
|
Time from date of randomization until the date of first documented CR or PR,assessed up to18 months
|
Duration of Response (DOR)
大体时间:Time from first documented evidence of CR or PR until the date of first documented progression ,assessed up to18 months
|
is defined as the time from first documented evidence of CR or PR until the date of first documented progression as assessed by RECIST 1.1 or death; assessed up to18 months
|
Time from first documented evidence of CR or PR until the date of first documented progression ,assessed up to18 months
|
Disease Control Rate (DCR)
大体时间:Time from date of randomization until the date of first documented Progression,assessed up to18 months
|
Percentage of Participants who have achieved CR, PR and SD to study treatment;
|
Time from date of randomization until the date of first documented Progression,assessed up to18 months
|
AE
大体时间:AEs(NCI CTCAE 5.0) collected at each cycle,Assessed up to18 months
|
Number of Subjects with treatment-related adverse events (AEs)Defined by all
|
AEs(NCI CTCAE 5.0) collected at each cycle,Assessed up to18 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:yi ba, PhD、Tianjin Medical University Cancer Institute and Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年9月15日
初级完成 (预期的)
2022年1月15日
研究完成 (预期的)
2022年1月15日
研究注册日期
首次提交
2020年8月5日
首先提交符合 QC 标准的
2020年9月14日
首次发布 (实际的)
2020年9月18日
研究记录更新
最后更新发布 (实际的)
2020年9月18日
上次提交的符合 QC 标准的更新
2020年9月14日
最后验证
2020年9月1日
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.
KH903 + Paclitaxel的临床试验
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Fujian Cancer HospitalJiangsu Hengrui Pharmaceutical Co., Ltd.; SunWay Biotech Co., LTD.尚未招聘肝转移 | 恶性黑色素瘤