NCT04555304Unknown2 期
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
Chengdu Kanghong Biotech Co., Ltd.0 个研究点目标入组 81 人开始时间: 2020年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 81
- 主要终点
- Progression-free survival（PFS）
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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/m
- •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
- •8.Life expectancy of ≥ 3 months.
排除标准
- •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.
- •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 KH
- •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.
研究组 & 干预措施
KH903 + Paclitaxel
Experimental
IV KH903 4 mg/kg IV paclitaxel 80 mg/m²
干预措施: KH903 + Paclitaxel (Drug)
Placebo + Paclitaxel
Active Comparator
IV Placebo IV paclitaxel 80 mg/m²
干预措施: Placebo + Paclitaxel (Drug)
结局指标
主要结局
Progression-free survival（PFS）
时间窗: 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
次要结局
- Objective Response Rate (ORR)(Time from date of randomization until the date of first documented CR or PR，assessed up to18 months)
- Duration of Response (DOR)(Time from first documented evidence of CR or PR until the date of first documented progression ，assessed up to18 months)
- Disease Control Rate (DCR)(Time from date of randomization until the date of first documented Progression，assessed up to18 months)
- AE(AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months)
研究者
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